Safety & PV Specialist I & II – Pharmacovigilance
Company: Syneos Health
Department: Safety & Pharmacovigilance
Location: Gurgaon / Hyderabad, India
Employment Type: Full-Time (Office-Based)
Job ID: 25110715
Experience Required:
Safety & PV Specialist I: Minimum 2.6 Years
Safety & PV Specialist II: Minimum 4 Years
Job Summary
The Safety & PV Specialist I & II is responsible for end-to-end Individual Case Safety Report (ICSR) processing, safety data management, regulatory reporting support, literature review, medical coding activities, and compliance with global pharmacovigilance regulations. The role supports clinical trial and post-marketing safety activities by ensuring accurate, timely, and compliant safety reporting.
Key Responsibilities
ICSR Processing & Case Management
Enter safety case information into PV quality and tracking systems.
Process ICSRs according to SOPs, safety plans, and project-specific requirements.
Perform ICSR triage and evaluate cases for:
Completeness
Accuracy
Regulatory reportability
Enter case information into safety databases.
Code:
Adverse events
Medical history
Concomitant medications
Laboratory tests
Prepare detailed and medically accurate case narratives.
Identify missing information and manage follow-up queries.
Identify and manage duplicate ICSRs.
Perform quality review of ICSRs.
Regulatory Reporting & Compliance
Support preparation and submission of expedited safety reports according to global regulatory requirements.
Maintain safety tracking activities for assigned projects.
Ensure timely and accurate safety reporting.
Maintain compliance with:
Standard Operating Procedures (SOPs)
Work Instructions (WIs)
GCP requirements
ICH guidelines
GVP requirements
Global drug, biologic, and medical device regulations
Medical Coding & Database Activities
Perform MedDRA coding activities.
Support drug dictionary maintenance.
Perform literature screening and safety review.
Validate and submit xEVMPD product records.
Perform MedDRA coding of indication terms.
Perform manual recoding of uncoded product and substance terms.
Support SPOR / IDMP-related activities.
Documentation & Quality Activities
Ensure safety documents are filed in:
Trial Master File (TMF) for clinical trials
Pharmacovigilance System Master File (PSMF) for post-marketing programs
Maintain audit-ready safety documentation.
Participate in audits and inspection readiness activities.
Apply regulatory intelligence into safety reporting activities.
Stakeholder Collaboration
Develop effective working relationships with:
Internal project teams
Sponsors
Cross-functional stakeholders
External partners
Support process improvement initiatives within pharmacovigilance operations.
Required Qualifications
Educational Qualification
Eligible qualifications:
B.Pharm
M.Pharm
BDS
BMS
MBBS
Not Eligible:
B.Sc
M.Sc
Experience Requirements
Safety & PV Specialist I
Minimum 2.6 years of Pharmacovigilance experience.
Safety & PV Specialist II
Minimum 4 years of Pharmacovigilance experience.
Required Skills
Strong understanding of ICSR lifecycle and safety reporting processes.
Knowledge of global pharmacovigilance regulations.
Experience with PV safety databases.
Knowledge of MedDRA coding.
Understanding of GCP, ICH guidelines, and GVP requirements.
Strong attention to detail and quality focus.
Excellent written and verbal communication skills.
Ability to manage multiple activities within strict timelines.
Preferred Experience
Hands-on experience with Argus Safety, ARISg, or similar PV databases.
Experience in clinical trial safety and post-marketing surveillance.
Knowledge of xEVMPD, SPOR, and IDMP activities.
Experience in literature screening and safety coding.
Experience handling global safety cases.
Estimated Salary Package (India)
Safety & PV Specialist I (2.6+ Years Experience):
₹6 – ₹10 LPA
Safety & PV Specialist II (4+ Years Experience):
₹9 – ₹15 LPA
Higher packages may be offered for candidates with strong expertise in Argus Safety, MedDRA coding, global regulatory submissions, medical device PV, and complex case processing experience.
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