Pharmacovigilance Medical Writer II Hiring at Primevigilance

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.

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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.

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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.

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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).

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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.

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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.

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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.

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Application Process

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

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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.

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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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Summary Table

Tagged as: Pharma Jobs in Pune