Location: Pune, India (Office-Based)
Company: Syneos Health
Job ID: 25107344
Shift: Night Shift (Mandatory)
Experience Required: Minimum 4 years (Not suitable for freshers)
About the Company
Syneos Health is a globally established, fully integrated biopharmaceutical solutions organization dedicated to accelerating drug development and commercialization. The company collaborates with leading innovators across the healthcare ecosystem, delivering end-to-end clinical and safety solutions that directly impact patient outcomes worldwide.
Job Overview
The Safety & Pharmacovigilance Specialist II is responsible for end-to-end Individual Case Safety Report (ICSR) processing, safety data review, and regulatory compliance activities. This role requires strong expertise in pharmacovigilance operations, including case triage, medical coding, narrative writing, and safety reporting in alignment with global regulatory standards.
This position is ideal for experienced pharmacovigilance professionals looking to advance their careers in a high-impact, global CRO environment.
Key Responsibilities
Perform accurate and timely processing of Individual Case Safety Reports (ICSRs) as per SOPs and project-specific safety plans
Conduct ICSR triage, ensuring completeness, accuracy, and regulatory reportability
Enter and manage safety data in pharmacovigilance databases
Code adverse events, medical history, concomitant medications, and laboratory data using MedDRA and relevant dictionaries
Develop detailed and medically sound narrative summaries
Identify missing or inconsistent data and perform follow-ups for query resolution
Support expedited reporting in compliance with global regulatory timelines
Perform literature screening and safety data review activities
Handle duplicate case identification and reconciliation
Support xEVMPD submissions and product data validation
Participate in SPOR/IDMP-related activities
Conduct quality review of ICSRs and ensure adherence to data integrity standards
Maintain Trial Master File (TMF) documentation and Pharmacovigilance System Master File (PSMF) compliance
Ensure adherence to ICH-GCP, GVP guidelines, SOPs, and global regulatory frameworks
Participate in audits and inspections as required
Collaborate effectively with cross-functional teams including Clinical Operations, Data Management, and Regulatory Affairs
Eligibility Criteria
Educational Qualification: B.Pharm, M.Pharm, BDS, BMS, or MBBS
Candidates with BSc or MSc are not eligible for this role
Minimum 4 years of hands-on experience in pharmacovigilance or drug safety
Strong knowledge of ICSR processing, MedDRA coding, and safety databases
Familiarity with global pharmacovigilance regulations (ICH, GVP)
Ability to work in night shifts is mandatory
Immediate or early joiners will be preferred
Important Note for Applicants
This is a mid-level pharmacovigilance role requiring prior industry experience. Freshers are advised to apply for entry-level roles such as Drug Safety Associate, PV Case Processor, or Trainee positions to build foundational expertise before progressing to Specialist-level roles.
Why This Role Stands Out
Opportunity to work on global safety databases and regulatory reporting systems
Exposure to advanced pharmacovigilance operations including xEVMPD and IDMP
Collaborative work environment within a leading global CRO
Strong career growth trajectory in drug safety and risk management
How to Apply
Candidates can apply through the official careers page of Syneos Health or explore verified global pharmacovigilance opportunities on ThePharmaDaily.com
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