Safety & Pharmacovigilance Specialist I
Location: Gurugram / Pune, India
Updated: November 11, 2025
Job ID: 25103034
Company: Syneos Health
About the Role
Syneos Health is seeking a Safety & Pharmacovigilance (PV) Specialist I to support global drug safety operations through efficient and compliant ICSR case processing. This position is ideal for professionals with hands-on PV experience who want to contribute to high-quality safety reporting within a global biopharmaceutical organization.
Syneos Health is a fully integrated biopharmaceutical solutions company operating across 110 countries, known for accelerating clinical development and supporting leading pharmaceutical and biotechnology partners worldwide.
Experience Required
2.5 to 4 years of experience in Pharmacovigilance
Strong experience in ICSR case processing
Hands-on knowledge of Argus or ArisG safety databases
Eligibility & Education
B. Pharm / M. Pharm
BDS / BMS / MBBS
Not eligible: B.Sc / M.Sc candidates
Strong understanding of medical terminology and PV operations
Job Responsibilities
Core PV Responsibilities
Perform ICSR data entry including booking, intake, and triage.
Process ICSRs according to SOPs, GVP modules, and project-specific safety plans.
Assess completeness, accuracy, and regulatory reportability of ICSR data.
Enter cases into safety databases and ensure accurate coding for:
Adverse events
Medical history
Concomitant medications
Laboratory tests
Narrative and Documentation Activities
Prepare high-quality narrative summaries.
Identify missing information, raise queries, and ensure timely resolution.
Maintain accurate safety tracking for assigned PV activities.
Regulatory and Compliance Activities
Support expedited reporting according to global regulatory timelines.
Perform literature screening and drug dictionary maintenance.
Process xEVMPD submissions, including MedDRA coding of product records.
Manage manual recoding of product and substance terms where required.
Identify and process duplicate ICSRs.
Contribute to SPOR / IDMP activities.
Quality and Review Activities
Conduct quality checks on processed ICSRs.
Ensure complete documentation in the Trial Master File (TMF) for clinical studies and PSMF for post-marketing programs.
Maintain compliance with:
SOPs
Work Instructions
Global drug/biologic/device regulations
ICH-GCP, GVP guidelines
Cross-Functional Collaboration
Build professional relationships with internal teams and external stakeholders.
Support audits and inspections as required.
Follow regulatory intelligence and apply current PV requirements to all activities.
Required Skills and Competencies
Proficiency in Argus or ArisG safety database systems.
Strong understanding of medical terminology and ICSR workflow.
Ability to manage timelines, ensure quality deliverables, and maintain compliance.
Excellent documentation, attention to detail, and PV process knowledge.
Strong communication and analytical skills.
About Syneos Health
Syneos Health supports clinical development globally and has contributed to:
94% of FDA-approved novel therapies in the past 5 years
95% of EMA-authorized products
200+ clinical studies across 73,000+ sites and 675,000+ trial participants
The company prioritizes career development, diverse perspectives, and an inclusive work culture.
Additional Information
This job description outlines primary responsibilities but is not exhaustive. Syneos Health may assign additional duties based on business needs. Equivalent experience may be considered where applicable.
The company complies with global employment regulations, including the ADA, and provides reasonable accommodations to support essential job functions.
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