Syneos Health is hiring for the position of Safety & PV Specialist (SS I) – Night Shift at its Gurugram office. Candidates with 2.6–4 years of pharmacovigilance (PV) experience and qualifications in B.Pharm, M.Pharm, BDS, BMS, or MBBS can apply.
The role involves Individual Case Safety Report (ICSR) processing, safety database management, medical coding, regulatory safety reporting, and quality-related activities. Candidates must be willing to work night shifts and attend the office in Gurugram. Immediate and early joiners will be preferred.
Job Details
| Particulars | Details |
|---|---|
| Company | Syneos Health |
| Job Role | Safety & PV Specialist (SS I) |
| Department | Pharmacovigilance |
| Job Location | Gurugram, Haryana |
| Work Mode | Office-based |
| Employment Type | Full-time |
| Shift | Night shift |
| Experience | 2.6–4 years of PV experience |
| Qualification | B.Pharm, M.Pharm, BDS, BMS, MBBS |
| Job Requisition ID | 25110762 |
| Joining Preference | Immediate/early joiners preferred |
Position: Safety & PV Specialist (SS I)
The selected candidate will support pharmacovigilance operations, including ICSR case processing, safety data entry, medical coding, quality checks, and regulatory reporting activities in accordance with applicable procedures and guidelines.
Key Responsibilities
- Process Individual Case Safety Reports (ICSRs) according to Standard Operating Procedures (SOPs) and project-specific safety plans.
- Enter and track safety information in pharmacovigilance quality systems and safety databases.
- Assess ICSR completeness, accuracy, and regulatory reportability.
- Code adverse events, medical history, concomitant medications, and medical tests.
- Prepare complete narrative summaries and follow up on queries to obtain missing information.
- Support timely and accurate expedited safety reporting.
- Perform literature screening and review for safety-related information.
- Conduct MedDRA coding, drug coding, and drug dictionary maintenance.
- Validate and submit xEVMPD product records, including indication coding.
- Identify and manage duplicate ICSRs and manually recode relevant product and substance terms.
- Support SPOR/IDMP-related activities.
- Perform quality reviews of ICSRs.
- Maintain relevant documentation in the Trial Master File (TMF) and Pharmacovigilance System Master File, as applicable.
- Follow applicable SOPs, work instructions, GCP, ICH guidelines, GVP, and global drug, biologic, and device regulations.
- Participate in audits and collaborate with internal and external project teams.
Eligibility and Qualifications
Candidates must meet the following requirements:
- Educational qualifications: B.Pharm, M.Pharm, BDS, BMS, or MBBS.
- Experience: 2.6–4 years of pharmacovigilance experience.
- Work location: Willingness to work from the Gurugram office.
- Shift requirement: Willingness to work night shifts.
- Joining availability: Immediate and early joiners will be preferred.
Important: B.Sc. and M.Sc. qualifications are explicitly excluded from the listed educational eligibility.
Required Skills and Knowledge
Relevant knowledge and experience for this role include:
- ICSR processing and case management.
- Safety database entry and case tracking.
- Medical coding and MedDRA.
- ICSR quality review and regulatory reportability assessment.
- Safety reporting and expedited reporting requirements.
- Literature screening and review.
- xEVMPD validation and submission.
- SPOR/IDMP activities.
- Compliance with SOPs, GCP, ICH guidelines, and GVP.
