Syneos Health is hiring a Safety & PV Specialist II for its Clinical Trial Case Processing team in Gurgaon, Haryana.
Applicants should have an MPharm, PharmD, BPharm, BDS, or equivalent life sciences qualification, plus 4 to 7 years of Pharmacovigilance experience.
The role covers end-to-end ICSR processing, clinical trial case management, medical literature monitoring, MedDRA coding, quality review, and regulatory compliance.
Job Details
| Particulars | Details |
| Company | Syneos Health |
| Job Role | Safety & PV Specialist II |
| Team | Clinical Trial Case Processing |
| Qualification | MPharm, PharmD, BPharm, BDS or equivalent |
| Experience | 4–7 years |
| Location | Gurgaon, Haryana |
| Work Mode | Onsite |
| Employment Type | Full Time |
About Syneos Health
Syneos Health is a global life sciences organisation providing clinical development and commercialisation services to the pharmaceutical, biotechnology and healthcare industries.
The company operates across the full drug development lifecycle, supporting clinical research, safety and health innovation.
Role & Responsibilities
The successful candidate will manage clinical trial safety cases and support global Pharmacovigilance activities, including case processing, medical literature review, coding, QC and regulatory reporting.
Clinical Trial Case Processing
- Perform end-to-end processing of Individual Case Safety Reports (ICSRs).
- Handle case intake, data entry, coding, narrative writing, follow-up and case completion.
- Enter and maintain safety information in pharmacovigilance databases and tracking systems.
- Ensure accuracy, completeness and compliance with project requirements.
- Process literature-derived ICSRs in accordance with the relevant SOPs, safety management plans and regulatory requirements.
Medical Literature Monitoring
- Conduct medical literature screening and review.
- Perform Medical Literature Monitoring (MLM) to identify potential adverse events and reportable safety information.
- Review published literature for relevant safety information.
- Process literature cases in accordance with the applicable procedures and regulatory requirements.
Coding and Quality Review
- Perform MedDRA coding and drug coding.
- Maintain medical dictionaries and associated coding information.
- Assess safety cases for medical and regulatory completeness, accuracy and consistency.
- Carry out quality reviews to ensure compliance with regulatory and client requirements.
- Identify, reconcile and manage duplicate safety cases across the various databases and tracking systems.
Regulatory Data Management and Compliance
- Support xEVMPD, SPOR and IDMP-related validation and submission activities.
- Assist with manual recoding of products, substances, indications and associated safety data.
- Maintain accurate and audit-ready safety documentation.
- Adhere to company SOPs, Work Instructions, Good Pharmacovigilance Practices (GVP) and ICH-GCP.
- Participate in audits, inspections and quality reviews.
- Support work with cross functional teams and global stakeholders to ensure on time project delivery.
Eligibility Criteria
Educational Qualification
Candidates should have one of the following qualifications:
- MPharm
- PharmD
- BPharm
- BDS
- Equivalent healthcare or life sciences qualification with 4 to 7 years of Pharmacovigilance experience.
- 4 to 7 years’ experience in Pharmacovigilance.
- Strong experience in Clinical Trial (CT) case processing.
- Experience in ICSR processing and case management.
- Experience in safety data entry, narrative writing and follow up.
- Experience in quality review and regulatory oversight activities.
Required Technical Skills
- Knowledge of Pharmacovigilance databases.
- MedDRA coding and drug dictionaries.
- Medical terminology.
- Clinical trial processes and safety reporting.
- ICH-GCP and GVP guidelines.
- Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.
Preferred Skills
- Literature case processing.
- Medical Literature Monitoring (MLM).
- xEVMPD requirements.
- SPOR and IDMP requirements.
- Duplicate case management and reconciliation.
- Audit and inspection support.
- Regulatory submission activities.
Additional Competencies
- Excellent written and verbal communication skills.
- Robust analytical and organisational skills.
- Attention to detail and accuracy.
- Ability to manage multiple deliverables and multiple deadlines.
- Ability to work independently as well as to work with global teams.
Job Location and Work Mode
Location: Gurgaon, Haryana, India.
Work Mode: Onsite.
This is a full time position with Syneos Health.
How to Apply
Interested and eligible candidates should apply through the official Syneos Health Careers website.
- Visit the official job application link.
- Review the job description and eligibility criteria carefully.
- Click on the Apply button.
- Fill out the online application form.
- Upload your updated CV and provide the required details.
- Submit your application online.
Job Summary
| Category | Details |
| Company | Syneos Health |
| Position | Safety & PV Specialist II |
| Team | Clinical Trial Case Processing |
| Qualification | MPharm, PharmD, BPharm, BDS or equivalent |
| Experience | 4–7 years |
| Key Skills | ICSR Processing, MedDRA, MLM, Clinical Trial Safety |
| Preferred Skills | xEVMPD, SPOR, IDMP |
| Location | Gurgaon, Haryana |
| Work Mode | Onsite |
| Employment Type | Full Time |
Frequently Asked Questions (FAQs)
1. What position is Syneos Health hiring for?
Syneos Health is recruiting for a Safety & PV Specialist II within its Clinical Trial Case Processing team.
2. What qualifications are eligible?
Candidates with MPharm, PharmD, BPharm, BDS or equivalent healthcare and life sciences qualifications are eligible to apply.
3. How much experience is required?
Candidates should have 4 to 7 years of Pharmacovigilance experience, with particular experience in clinical trial case processing.
4. Is clinical trial case processing experience required?
Yes. A strong level of experience in Clinical Trial (CT) case processing and ICSR management is required.
5. What are the main responsibilities?
The role involves ICSR processing, narrative writing, medical literature monitoring, MedDRA coding, quality review, duplicate case management and regulatory data management.
6. Is Medical Literature Monitoring experience preferred?
Yes. Experience in literature case processing and Medical Literature Monitoring (MLM) is preferred.
7. What’s the job location?
The office is in Gurgaon, Haryana, India.
8. Is this an onsite or remote role?
The job advert states that it is an onsite role.
9. How can candidates apply?
Eligible candidates can apply via the official Syneos Health Careers site using the application link provided above.