Job Title: Senior Safety & Pharmacovigilance (PV) Specialist
Company: Syneos Health
Location: Gurugram / Hyderabad, India (Office-based)
Job ID: 25107898
Employment Type: Full-time
Department: Safety & Pharmacovigilance Operations
Experience Required: Minimum 6+ years of Pharmacovigilance experience with strong expertise in ICSR case processing, quality review (QC), safety database management, and regulatory safety reporting.
Education: B.Pharm / M.Pharm / BDS / BMS / MBBS (B.Sc/M.Sc not eligible)
Salary Package: ₹12–22 LPA (Estimated as per current market standards for Senior Safety & PV Specialist roles in India; final compensation depends on ICSR processing expertise, QC experience, regulatory exposure, and interview performance.)
Role Summary
The Senior Safety & PV Specialist will manage end-to-end Individual Case Safety Report (ICSR) processing activities, ensure quality and regulatory compliance, perform safety data review, and support global Pharmacovigilance operations according to ICH-GCP, GVP, and regulatory requirements.
Key Responsibilities
ICSR Case Processing & Safety Database Management
Enter and manage safety case information in Pharmacovigilance quality and tracking systems.
Process ICSRs according to:
Company SOPs
Safety Management Plans
Regulatory requirements
Perform ICSR triage and evaluate:
Completeness
Accuracy
Regulatory reportability
Enter safety data into PV databases.
Code:
Adverse events
Medical history
Concomitant medications
Laboratory tests
Safety Data Review & Quality Control
Perform Quality Control (QC) review of ICSRs.
Ensure accuracy, consistency, and compliance of safety reports.
Identify missing information and generate follow-up queries.
Track query resolution until completion.
Identify and manage duplicate safety cases.
Perform manual recoding of un-coded product and substance terms.
Regulatory Safety Reporting
Support preparation and submission of expedited safety reports.
Ensure timely and accurate regulatory submissions.
Apply global safety reporting requirements and regulatory intelligence.
Maintain compliance with:
FDA regulations
EMA requirements
ICH guidelines
GVP guidelines
Medical Coding & Literature Review
Perform literature screening and safety review activities.
Conduct:
MedDRA coding
Drug coding
Medical terminology review
Maintain drug dictionaries and coding standards.
Support xEVMPD product record validation and submissions.
Perform indication coding using MedDRA.
SPOR / IDMP Activities
Support activities related to:
SPOR data management
Identification of Medicinal Products (IDMP)
Ensure product and substance data accuracy.
Documentation & Compliance
Ensure safety documents are filed correctly in:
Trial Master File (TMF)
Pharmacovigilance System Master File (PSMF)
Participate in:
Internal audits
Client audits
Quality reviews
Maintain compliance with:
SOPs
Work Instructions
GCP
ICH Guidelines
GVP Regulations
Global drug/biologic/device regulations
Required Technical Skills
Individual Case Safety Report (ICSR) Processing
ICSR Quality Control (QC)
Pharmacovigilance Operations
Safety Database Management
Adverse Event Coding
MedDRA Coding
Drug Dictionary Management
Literature Screening
Regulatory Safety Reporting
xEVMPD Product Records
SPOR / IDMP Knowledge
TMF Filing
GVP & ICH Guidelines
Mandatory Skills
Minimum 6 years of Pharmacovigilance experience
Strong ICSR case processing experience
Hands-on Quality Check (QC) experience mandatory
Knowledge of global PV regulations
Experience with safety databases preferred
Preferred Experience
CRO experience preferred.
Global clinical trial safety experience.
Exposure to post-marketing safety activities.
Experience working with multinational pharmaceutical clients.
Key Competencies
Strong attention to detail.
Excellent analytical and problem-solving skills.
Ability to manage complex safety cases.
Strong written and verbal communication skills.
Ability to work independently and collaboratively.
Good understanding of drug development processes.
Work Location
Gurugram / Hyderabad (Office-based)
Career Opportunity
Opportunity to work on global Pharmacovigilance programs.
Exposure to international regulatory frameworks.
Growth opportunities within Clinical Safety and PV operations.
Collaboration with global pharmaceutical and biotech teams.
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