Location: Hyderabad / Gurugram / Pune, India (Office-Based)
Company: Syneos Health
Job ID: 25107344
Experience Required:
Safety & PV Specialist I: Minimum 2.6 years
Safety & PV Specialist II: Minimum 4 years
Freshers: Not eligible for this role
About the Company
Syneos Health is a globally established biopharmaceutical solutions organization delivering end-to-end clinical development, commercialization, and consulting services. The company partners with leading pharmaceutical innovators to accelerate drug development and improve patient outcomes worldwide.
Job Overview
The Safety & Pharmacovigilance Specialist II is responsible for end-to-end case processing, safety data review, and regulatory compliance within global pharmacovigilance operations. This role is critical for ensuring high-quality Individual Case Safety Report (ICSR) processing, accurate medical coding, and timely submission of safety data in compliance with global regulatory standards.
This is a night shift role, requiring flexibility to work in global time zones.
Key Responsibilities
Perform intake, triage, and processing of Individual Case Safety Reports (ICSRs) in accordance with SOPs and project-specific safety plans
Evaluate case data for completeness, accuracy, and regulatory reportability
Enter and manage safety data in pharmacovigilance databases
Conduct medical coding using MedDRA and WHO Drug Dictionary for adverse events, medical history, and concomitant medications
Prepare detailed and compliant case narratives
Identify missing or unclear information and initiate follow-ups to resolve queries
Ensure timely submission of expedited safety reports as per global regulatory requirements
Perform duplicate detection and reconciliation of ICSRs
Conduct literature screening and safety signal identification activities
Support xEVMPD submissions and product data validation, including MedDRA coding for indications
Participate in SPOR/IDMP-related activities
Perform quality review and quality control of safety cases
Ensure proper documentation in Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF)
Maintain compliance with ICH-GCP, GVP guidelines, SOPs, and global regulatory requirements
Collaborate with cross-functional teams including Clinical Operations, Data Management, and Regulatory Affairs
Participate in internal and external audits and inspections
Required Qualifications
Education: B.Pharm, M.Pharm, BDS, BMS, or MBBS (BSc/MSc not eligible)
Minimum 4 years of experience in pharmacovigilance case processing for Specialist II role
Strong understanding of ICSR processing, MedDRA coding, and global safety reporting requirements
Hands-on experience with safety databases such as Argus, ArisG, or similar
Familiarity with regulatory guidelines including ICH, GVP, and FDA/EMA reporting standards
Ability to work in night shifts and manage high-volume case processing environments
Preferred Candidate Profile
Immediate or early joiners will be given preference
Strong analytical thinking and attention to detail
Effective communication and stakeholder management skills
Ability to work in a fast-paced, compliance-driven environment
Why This Role Matters
This role offers direct exposure to global pharmacovigilance operations, including regulatory submissions, safety data analysis, and real-world drug safety monitoring. It is ideal for professionals looking to advance their careers in drug safety, risk management, and regulatory compliance within a leading global CRO environment.
Important Note for Applicants
This is an experienced-level pharmacovigilance role. Freshers are advised to begin with entry-level roles such as Drug Safety Associate or PV Case Processor before progressing to Specialist-level positions.
How to Apply
Apply through the official careers portal of Syneos Health or explore verified global pharmacovigilance jobs on ThePharmaDaily.com to accelerate your career in drug safety and clinical research.
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Canada |Quebec :
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