Job Tag: Pharma Jobs in Pune

B.Pharm, M.Pharm Pharmacovigilance Openings | TCS Drug Safety Associate – Pune

Apply for Drug Safety Associate role at Tata Consultancy Services, Pune. Open for B.Pharm, M.Pharm, BHMS, BAMS, BDS, MSc candidates with 1–5 years experience.

Tata Consultancy Services (TCS), a global leader in IT services and life sciences solutions, is inviting applications for the role of Drug Safety Associate in its Pharmacovigilance division at Pune. This position offers an exciting opportunity for life science professionals to work with cutting-edge safety data systems, contribute to global patient safety, and grow within one of India’s most respected multinational corporations.

Company Overview

Tata Consultancy Services (TCS) is one of the largest global IT and consulting firms, recognized for its innovative healthcare and life sciences solutions. With over 600,000 employees across 46 countries, TCS has a strong presence in the pharmaceutical domain, offering services in clinical research, pharmacovigilance, regulatory affairs, and data analytics.

The company focuses on leveraging technology-driven pharmacovigilance solutions that ensure compliance, safety, and efficacy of medicinal products worldwide. Working at TCS means being part of a culture that values continuous learning, diversity, and innovation.

Job Role & Responsibilities

As a Drug Safety Associate at TCS, you will play a vital role in ensuring patient safety through efficient management of adverse event data and regulatory compliance. Your responsibilities include:

• Reviewing, coding, and assessing case safety reports in Oracle Argus or equivalent systems.
• Performing all pharmacovigilance (PV) case-handling steps accurately and within timelines.
• Ensuring compliance with global regulatory guidelines and company standard operating procedures (SOPs).
• Conducting follow-up activities and maintaining high-quality case documentation.
• Supporting continuous process improvements and training initiatives.
• Collaborating with cross-functional safety and clinical data teams to enhance quality and performance metrics.

This role demands strong analytical and decision-making skills along with meticulous attention to detail.

Eligibility / Qualifications

To qualify for the Drug Safety Associate role at TCS, candidates must meet the following criteria:

Educational Qualifications:

• B.Pharm / M.Pharm
• BHMS / BAMS / BDS
• M.Sc (Biotechnology, Zoology, or related life science streams)

Experience Required:

• 1 to 5 years of relevant experience in Pharmacovigilance or Drug Safety operations.

Essential Skills:

• Hands-on experience with Argus Safety database or equivalent systems.
• Familiarity with MedDRA coding, case triage, and expedited reporting.
• Knowledge of global regulatory requirements (e.g., ICH, EMA, FDA, and CDSCO guidelines).
• Excellent written and verbal communication skills.

Location & Work Environment

Work Location: Pune, Maharashtra
Work Mode: On-site, Full-time

TCS offers a highly collaborative and learning-centric work environment with structured mentorship programs and opportunities for career advancement within the pharmacovigilance domain.

Salary & Benefits

• Competitive industry salary based on experience and qualifications.
• Performance-based incentives and bonuses.
• Medical insurance, life cover, and other employee wellness benefits.
• Access to global learning resources and certifications through TCS Learning Hub.

Application Process

Interested candidates can apply directly through the official TCS Careers Portal or reach out to Manisha Singh, Talent Acquisition Specialist (Life Sciences, Pharma & Healthcare) for more details.

Application Tip: Apply early – the company review time is typically one week. Don’t miss the opportunity to join one of India’s top global employers.

Why Join TCS Pharmacovigilance?

• Work on global safety databases ensuring patient safety compliance across multiple geographies.
• Opportunity to collaborate with leading pharmaceutical companies.
• Build long-term career growth in pharmacovigilance and regulatory operations.
• Exposure to cutting-edge data analytics and AI-powered PV tools.

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Frequently Asked Questions (FAQs)

1. What is the eligibility for the Drug Safety Associate position at TCS Pune?
Candidates with degrees in B.Pharm, M.Pharm, BHMS, BAMS, BDS, or M.Sc (Biotech/Zoology) and 1–5 years of pharmacovigilance experience are eligible.

2. Does TCS hire freshers for pharmacovigilance roles?
Yes, TCS occasionally recruits freshers through campus drives or training programs. However, this particular role prefers experienced professionals.

3. What tools are commonly used at TCS for PV case processing?
TCS primarily utilizes Oracle Argus Safety for case processing and safety data management.

4. What is the typical salary range for this role?
Salaries vary based on experience, but professionals can expect a range of ₹3.5 – ₹8 LPA depending on skill set and domain expertise.

5. How soon should I apply?
The hiring process moves fast — candidates are encouraged to apply within one week of the posting to maximize their chances.

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Written by PharmaStuff – India’s #1 platform for verified pharma and clinical research job updates.

Regulatory Affairs Associate Vacancies | Syneos Health, Pune

Apply for Senior Regulatory Associate (Module 1) at Syneos Health, Pune. MSc Pharma candidates with 4+ years of experience. Remote options available.

Syneos Health, a global leader in biopharmaceutical solutions, is inviting applications for the position of Senior Regulatory Associate (Module 1). This full-time opportunity based in Pune, India (remote flexibility) is ideal for professionals with a background in pharmaceutical sciences and regulatory documentation. If you’re passionate about compliance, drug submissions, and working in a dynamic clinical research environment, this role offers the perfect platform to grow your career.

Company Overview

Syneos Health is a world-renowned biopharmaceutical solutions company operating across 110 countries with a mission to accelerate clinical, medical, and commercial outcomes. With over 29,000 professionals worldwide, the company collaborates with top pharmaceutical and biotech organizations to deliver end-to-end drug development and commercialization services.

In the last five years alone, Syneos Health has contributed to:

• 94% of all Novel FDA Approved Drugs
• 95% of EMA Authorized Products
• Over 200 clinical studies across 73,000+ sites

Their culture of innovation, inclusivity, and integrity makes Syneos Health one of the most trusted names in global healthcare operations.

Job Role & Responsibilities

As a Senior Regulatory Associate (Module 1), you will play a critical role in ensuring global regulatory compliance and documentation excellence. The position involves preparation, coordination, and submission of critical regulatory dossiers in accordance with international standards.

Key Responsibilities:

• Prepare and compile Module 1 documents and gather country-specific administrative forms.
• Assist in the preparation of INDs, NDAs, MAAs, DMFs, and other regulatory submissions.
• Draft responses to Health Authority (HA) queries and ensure commitment tracking.
• Maintain regulatory trackers, submission timelines, and status reports for ongoing projects.
• Ensure accurate documentation archiving and compliance with internal SOPs.
• Conduct regulatory research to identify precedents, orphan drug designations, and policy updates.
• Support clients and internal teams by providing regulatory guidance and documentation insights.
• Manage correspondence and ensure smooth communication flow across regulatory affairs teams.

This role offers exposure to both regional and global submission strategies, giving you the chance to strengthen your expertise in international regulatory operations.

Eligibility / Qualifications

To qualify for this position, candidates must demonstrate strong regulatory experience combined with academic excellence.

Educational Qualification:

• Master’s degree in Pharmaceutical Sciences, Regulatory Affairs, or Pharmacology.

Preferred Courses:
Pharmaceutical Sciences, Drug Regulatory Affairs, Pharmacology, Quality Assurance, Pharmaceutical Chemistry.

Experience Required:

• Minimum 4 years of experience in regulatory affairs, quality documentation, or pharma compliance.
• Advanced proficiency in Microsoft Office applications.
• Strong analytical, project management, and communication skills.

Location & Salary

Work Location: Pune, Maharashtra (Remote work flexibility available)

Compensation: Competitive and commensurate with experience.

Syneos Health values its employees and provides comprehensive benefits including professional growth opportunities, cross-functional training, and global exposure.

Application Process

Interested candidates can apply directly via the official career portal using the link below:

👉 Apply Here – Syneos Health Career Portal

FAQs

Q1. Who can apply for the Senior Regulatory Associate position at Syneos Health?
Candidates with an M.Sc. in Pharmaceutical Sciences and 4+ years of regulatory experience are eligible.

Q2. Is remote work available for this position?
Yes, the role offers remote flexibility within India.

Q3. What are the main responsibilities of this role?
Key responsibilities include regulatory documentation, Module 1 submissions, Health Authority communication, and tracking compliance reports.

Q4. How can I apply?
Apply via the official Syneos Health portal.

Q5. What is the expected salary range?
The salary is competitive and depends on experience, current CTC, and role fitment.

Call to Action

Don’t miss this opportunity to join a global leader in pharmaceutical development.
Apply now to be part of a mission-driven team transforming healthcare innovation!
Limited openings – Apply before slots fill up!

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Safety & PV Ops Specialist II (ARGUS / Veeva) | Syneos Health | Pune

Hiring Safety & PV Ops Specialist II at Syneos Health, Pune. Life science graduates with ARGUS or Veeva Safety experience preferred.

Syneos Health, a global biopharmaceutical leader, is seeking an experienced Safety & Pharmacovigilance Operations Specialist II – Technology Support (ARGUS Console or Veeva Safety preferred) to join its dynamic team in Pune, India. This role offers the opportunity to contribute to life-saving drug safety initiatives, collaborate across global teams, and advance your career in pharmacovigilance technology support.

Company Overview

Syneos Health® is a leading integrated biopharmaceutical solutions organization with a mission to accelerate customer success and improve patient outcomes worldwide. Operating in over 110 countries, Syneos Health combines clinical development, medical affairs, and commercial expertise to bring life-changing therapies to market. The company partners with 94% of novel FDA-approved drugs and 95% of EMA-authorized products, demonstrating its global influence and credibility in the pharmaceutical industry.

At Syneos Health, employees are encouraged to innovate and challenge the status quo while being supported through professional development, inclusive culture, and total rewards programs. Their “Total Self” culture fosters authenticity, belonging, and collaboration among over 29,000 employees worldwide.

Job Role & Responsibilities

As a Safety & PV Operations Specialist II – Technology Support, you will play a critical role in maintaining pharmacovigilance (PV) systems and ensuring regulatory compliance for global safety operations. The position involves technical expertise in ARGUS Console or Veeva Safety platforms and close collaboration with cross-functional teams.

Key Responsibilities:

• Assist in managing and maintaining the global safety database systems (ARGUS / Veeva Safety), including user setup, configuration, upgrades, and data migration.
• Perform MedDRA and WHO Drug Dictionary updates and ensure database compliance with regulatory reporting standards.
• Develop, update, and maintain Job Aids, SOPs, and technical documentation for PV systems.
• Generate, validate, and maintain safety reports, listings, and queries for internal, client, or regulatory use.
• Support ongoing safety data migration and validation activities, ensuring data accuracy and completeness.
• Participate in project and cross-functional meetings, providing system support and pharmacovigilance insights.
• Maintain compliance with FDA, EMA, and ICH guidelines for drug safety and pharmacovigilance operations.
• Manage system performance qualification (PQ) testing, routine patch updates, and validation activities.
• Support Syneos Health’s global pharmacovigilance initiatives by ensuring robust technology support and regulatory alignment.

Eligibility / Qualifications

Educational Background:

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Computer Science, or related technical field.

Experience Requirements:

• 2–5 years of experience in pharmacovigilance operations, safety database management, or regulatory systems.
• Prior hands-on experience with ARGUS Console or Veeva Safety systems is highly desirable.
• Excellent knowledge of ICH, FDA, and EU pharmacovigilance guidelines.

Technical Skills:

• Strong command of Microsoft Office Suite (Word, Excel, PowerPoint, Visio).
• Understanding of MedDRA, WHO-DD, and regulatory submission processes.
• Ability to manage multiple tasks, prioritize efficiently, and meet deadlines.

Soft Skills:

• Strong written and verbal communication skills.
• High attention to detail and documentation accuracy.
• Analytical mindset with problem-solving orientation.
• Proven ability to work independently and in global team settings.

Location & Salary

Location: Pune, India
Work Mode: Remote / Full-Time
Compensation: Competitive and based on experience. Syneos Health offers performance-linked incentives, health benefits, and continuous learning opportunities.

Application Process

Interested and qualified candidates can apply directly through the official Syneos Health career portal using the link below:

👉 Apply Here

Ensure your resume highlights relevant experience with ARGUS or Veeva systems and pharmacovigilance expertise. Early applications are encouraged to secure priority consideration.

Why Join Syneos Health

• Collaborate with global pharmaceutical leaders and participate in breakthrough projects.
• Work on innovative technology platforms that enhance drug safety and reporting accuracy.
• Be part of an inclusive, diverse, and empowering workplace that values your growth.
• Access world-class training and certification programs in pharmacovigilance and regulatory affairs.

Career Growth Opportunities

Syneos Health is known for promoting talent from within. Employees in PV Operations roles can advance to Senior Safety Specialist, Safety Data Manager, or Global PV Technology Lead positions. The company provides structured learning pathways in:

• Pharmacovigilance Data Management
• Drug Safety Coding and Case Processing
• Safety Database Administration (Oracle ARGUS, Veeva Vault)
• Clinical Safety Operations
• Regulatory Intelligence and Compliance

Suggested Courses & Certifications

To strengthen your career prospects, consider certifications like:

• Advanced Pharmacovigilance and Clinical Research
• ARGUS Safety Database Training
• Veeva Vault Safety Certification
• ICH-GCP and Drug Safety Regulations
• Regulatory Affairs and Quality Compliance

These courses can significantly improve your chances of selection and help you excel in this specialized domain.

Frequently Asked Questions (FAQs)

1. Who can apply for this position?
Candidates with a degree in life sciences, pharmacy, or computer science and experience with ARGUS or Veeva Safety systems are ideal for this role.

2. Is this a remote position?
Yes, this is a remote full-time position based in Pune, offering flexibility for qualified professionals.

3. What kind of experience is required?
2–5 years of pharmacovigilance technology or safety database management experience is preferred.

4. What are the career growth options in Syneos Health?
You can progress into senior PV, data management, or safety system leadership roles with continued training and experience.

5. When is the last date to apply?
Applications are reviewed on a rolling basis. Apply soon to increase your chances of consideration.

Call to Action

Don’t miss this opportunity to work with one of the world’s top biopharmaceutical solutions organizations.
Apply now and contribute to global patient safety and regulatory excellence.

🔗 Click here to apply now

📅 Apply before positions fill up! Secure your place today.

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Pharmacovigilance Medical Writer II – Life Science, MD | Pune

Apply for Pharmacovigilance Medical Writer II at PrimeVigilance, Pune. Life Science or Pharmacy graduates with PV writing experience preferred. adriana olivarez nude candyflv

PrimeVigilance, part of the renowned Ergomed Group, is hiring an experienced Pharmacovigilance Medical Writer II for its expanding Medical Writing team in Pune, India. If you have a strong background in pharmacovigilance, regulatory writing, and clinical safety documentation, this opportunity offers you a platform to contribute to global drug safety and patient care.

This role is ideal for professionals who excel at crafting precise scientific documents while ensuring compliance with global regulatory standards such as EMA, FDA, and ICH. Join a global leader in pharmacovigilance and medical writing services known for its commitment to quality, training, and professional growth.

Company Overview

PrimeVigilance, a part of the Ergomed Group, was founded in 2008 and has since evolved into a global leader in pharmacovigilance, medical writing, and regulatory affairs. Headquartered in the UK, PrimeVigilance operates across Europe, North America, and Asia, providing comprehensive services including:

• Pharmacovigilance & Risk Management

• Medical Information

• Regulatory Affairs

• Quality Assurance

The company collaborates with both emerging and established pharmaceutical and biotechnology firms, offering strategic and operational support to ensure patient safety and regulatory compliance.

PrimeVigilance believes in investing in its people — providing continuous learning, career growth, and mental well-being initiatives. The company culture emphasizes diversity, work-life balance, and global collaboration, fostering a dynamic environment where innovation thrives.

Job Role & Responsibilities

As a Pharmacovigilance Medical Writer II, you will play a crucial role in authoring, reviewing, and managing key safety and regulatory documents for global clients. Your writing will contribute directly to maintaining the highest standards of patient safety and regulatory compliance.

Key Responsibilities:

• Prepare and review aggregate safety reports such as PSURs, PBRERs, DSURs, RMPs, PADERs, and ACOs.

• Ensure scientific accuracy, clarity, and regulatory compliance across all deliverables.

• Conduct quality control (QC) and peer review of medical writing deliverables from the operations team.

• Collaborate with Project Managers to manage report timelines and deliverables.

• Participate in client kick-off meetings, audits, and inspections as required.

• Support training programs for new and junior medical writers.

• Coordinate with the Quality, Compliance, and Training team to implement process improvements and update SOPs or templates.

• Maintain detailed documentation in alignment with Good Pharmacovigilance Practices (GVP).

Eligibility / Qualifications

To qualify for this role, you should have both educational credentials and hands-on pharmacovigilance experience.

Educational Background:

• MD, Pharmacy, or Life Sciences degree (Master’s or PhD preferred).

• Relevant specializations: Pharmacology, Toxicology, Pharmaceutical Sciences, Biotechnology, or Clinical Research.

• Recommended certifications/courses:

  • Good Pharmacovigilance Practices (GVP)

  • Medical Writing Certification (AMWA/EMWA)

  • ICH Guidelines and Regulatory Writing Workshops

Experience Required:

• Strong background in pharmacovigilance, including case processing, signal detection, and risk management.

• Prior experience within a CRO or pharma regulatory writing environment preferred.

• Excellent attention to detail and ability to manage multiple writing projects simultaneously.

• Proven capability to mentor and guide Associate Medical Writers.

• Excellent English communication skills; proficiency in an additional language is advantageous.

Location & Salary

📍 Location: Pune, Maharashtra, India
💼 Employment Type: Full-time
💰 Salary: Competitive and based on experience

PrimeVigilance offers a supportive and flexible work environment, enabling employees to maintain a healthy work-life balance while contributing to impactful healthcare outcomes.

Why Join PrimeVigilance

Joining PrimeVigilance means becoming part of an organization that values quality, ethics, and personal development. Employees enjoy:

• Structured career development programs and continuous learning opportunities.

• Exposure to global pharmacovigilance projects and international collaborations.

• Supportive work culture emphasizing diversity, inclusion, and belonging.

• Internal mobility and opportunities for cross-functional growth within the Ergomed Group.

Core Values:

• Quality

• Integrity & Trust

• Drive & Passion

• Agility & Responsiveness

• Belonging & Collaboration

If these values resonate with your professional outlook, you’ll thrive in PrimeVigilance’s mission-driven environment.

Application Process

Interested candidates can apply directly through the official application portal:
👉 Apply Here

FAQs – Pharmacovigilance Medical Writer II at PrimeVigilance

1. What qualifications are needed for this medical writing role?
Candidates should hold a degree in Pharmacy, Medicine, or Life Sciences, ideally with prior pharmacovigilance experience.

2. Is this role open to freshers?
No, this position is intended for professionals with prior experience in pharmacovigilance or medical writing.

3. What documents will I be responsible for writing?
Key deliverables include PSURs, PBRERs, DSURs, RMPs, and PADERs.

4. Does PrimeVigilance offer remote or hybrid options?
Yes, depending on project needs, hybrid work flexibility may be available.

5. How can I increase my chances of selection?
Highlight experience in PV systems, regulatory submissions, and safety report preparation in your resume.

Call to Action

🚀 Don’t miss your chance to join a leading global pharmacovigilance team!
Apply now and advance your career in medical writing and drug safety with PrimeVigilance.
👉 Apply Today

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