Job Title: Safety & Pharmacovigilance (PV) Specialist I
Job ID: 25103034
Location: Gurugram / Pune, India
Employment Type: Full-Time
Company: Syneos Health
About Syneos Health
Syneos Health is a fully integrated biopharmaceutical solutions organization supporting clinical development, medical affairs, and commercial execution. With 29,000 employees across 110 countries, Syneos partners with clients to accelerate the development of new therapies and improve patient outcomes.
The company fosters:
Career growth and internal mobility
Supportive leadership and mentorship
Inclusive “Total Self” culture promoting diversity and belonging
Role Summary
The Safety & PV Specialist I is responsible for performing Individual Case Safety Report (ICSR) case processing and safety data management in accordance with regulatory guidelines, company SOPs, and project requirements.
Required Experience & Education
|
Requirement |
Details |
|---|---|
|
Experience |
2.5–4 years in Pharmacovigilance & ICSR Case Processing |
|
Education |
B.Pharm / M.Pharm / BDS / BMS / MBBS (No B.Sc / M.Sc) |
|
PV Tools |
Experience with Argus Safety Database or Aris-G |
|
Skills |
Medical coding, narrative writing, regulatory reporting, drug safety knowledge |
Key Responsibilities
Perform ICSR case data entry, triage, and processing as per SOPs.
Evaluate case information for accuracy, completeness, and regulatory reportability.
Enter and maintain safety data in PV safety databases.
Perform MedDRA coding for adverse events, medical history, lab tests, and medications.
Prepare narrative summaries and identify missing information requiring queries.
Support expedited safety report submissions in compliance with regulatory timelines.
Conduct literature screening for safety signal identification.
Maintain product & substance entries in xEVMPD and manage coding/updates.
Identify and manage duplicate ICSRs.
Ensure accurate documentation submission into TMF (Trial Master File) or PV System Master File.
Ensure adherence to:
GCP (Good Clinical Practice)
GVP (Good Pharmacovigilance Practice)
Global drug safety regulations
ICH guidelines and project-specific safety plans
Participate in audits when required and maintain high-quality documentation standards.
Key Competencies
|
Competency |
Description |
|---|---|
|
Attention to Detail |
Accuracy in case evaluation & coding |
|
Regulatory Understanding |
Knowledge of global PV & safety reporting requirements |
|
Medical Terminology Knowledge |
Strong understanding of clinical & drug-related terms |
|
Communication |
Ability to coordinate with internal/external stakeholders |
|
Team Collaboration |
Works constructively with cross-functional teams |
Why Work at Syneos Health
Career development and continuous training opportunities
Recognition & rewards programs
Inclusive work culture where everyone feels valued
Work that contributes directly to patient safety and public health
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