Syneos Health Hiring Safety & PV Specialist | B Pharm graduates | Apply Now For Pharma Job
Looking for a rewarding Pharmacovigilance Job in the life sciences industry? Syneos Health is hiring for the position of Safety & PV Specialist I. This excellent Pharma Job opportunity is ideal for candidates with experience in ICSR case processing, post-marketing safety, and pharmacovigilance operations. Join a leading global organization and build a successful career in drug safety and clinical development.
- Job Position: Safety & PV Specialist I
- Location: Hyderabad
About the Company
Syneos Health is a leading, fully integrated life sciences services organization focused on accelerating customer success across the drug development and commercialization continuum. The company partners with innovators worldwide and provides expertise in clinical development, commercialization, and pharmacovigilance services.
Over the past 5 years, Syneos Health has worked with 94% of all novel FDA-approved drugs, 95% of EMA-authorized products, and supported over 200 studies across 73,000 sites and 675,000+ trial patients globally.
Job Description
Syneos Health is hiring Safety & PV Specialist I professionals for its Pharmacovigilance & Safety team. The role includes ICSR processing, safety reporting, literature review, MedDRA coding, duplicate management, xEVMPD submissions, and post-marketing pharmacovigilance activities.
Candidates will work closely with clinical and safety teams while ensuring compliance with SOPs, GCP, ICH guidelines, GVP, and global pharmacovigilance regulations.
Key Responsibilities
- Process and track ICSRs in PVG systems.
- Perform ICSR triage, data review, and safety database entry.
- Code events, medications, and medical history using MedDRA.
- Prepare narrative summaries and follow up on safety queries.
- Generate expedited safety reports as per regulatory guidelines.
- Conduct literature review, drug coding, and duplicate ICSR management.
- Validate xEVMPD records and support SPOR/IDMP activities.
- Perform quality review of ICSRs and maintain TMF documentation.
- Ensure compliance with SOPs, GCP, ICH, GVP, and safety regulations.
- Participate in audits and collaborate with project teams.
Qualifications
- Bachelor’s Degree in Pharmacy or equivalent experience.
- 2–4 years of ICSR case processing experience in spontaneous, clinical trial, and literature cases.
- Post-marketing case processing experience is mandatory.
- Knowledge of safety databases, medical terminology, ICH GCP, GVP, and pharmacovigilance regulations.
- Understanding of clinical trial processes across Phases II–IV.
- Proficiency in MS Office, Outlook, Visio, and internet applications.
- Strong communication, organizational, and multitasking skills.
- Ability to work independently and within a team environment.
- Detail-oriented with high accuracy and deadline management skills.
