Safety & PV Specialist Job At Syneos Health
Syneos Health is hiring a Safety & Pharmacovigilance Specialist I for a remote role in India. This Pharmacy Job position is ideal for life sciences, pharmacy, or nursing professionals looking to build a global career in ICSR processing, safety database management, and regulatory-compliant pharmacovigilance operations within a leading biopharmaceutical solutions organization. Graduates seeking Pharmacy Jobs or Pharmacist Jobs can apply now.
About the Company
Syneos Health is a fully integrated biopharmaceutical solutions organization operating across 110 countries, supporting clinical development, medical affairs, and commercialization. Known for its patient-centric approach and global reach, Syneos Health has contributed to 94% of novel FDA-approved drugs and 95% of EMA-authorized products in recent years. This Pharmacy Job role plays a significant role in the company.
Educational Requirements
- Bachelor’s degree in Pharmacy
- Equivalent combination of education and relevant experience may be considered
Experience & Knowledge Requirements for this Pharmacy Job
- Understanding of pharmacovigilance processes
- Knowledge of clinical trials (Phase II–IV) and/or post-marketing safety
- Familiarity with ICH GCP, GVP, and global PV regulations
- Experience with safety databases and medical terminology
Key Responsibilities for this Pharmacy Job
- Enter and track ICSRs in pharmacovigilance quality and safety systems
- Assist in processing ICSRs as per SOPs and project-specific safety plans
- Triage safety cases and evaluate data for completeness, accuracy, and reportability
- Perform data entry, coding, and narrative writing for safety cases
- Code adverse events, medical history, concomitant medications, and tests using MedDRA
- Identifying missing information, raising queries, and following up until resolution is essential for this Pharmacy Job role
- Support expedited safety reporting in line with regulatory timelines
- Perform literature screening and safety review
- Support xEVMPD submissions, SPOR/IDMP activities, and product record maintenance
- Identify and manage duplicate ICSRs
- Perform quality review of safety cases
- Ensure submission of safety documents to TMF and PV System Master File
- Participate in audits and inspections as required
- Maintain compliance with SOPs, WIs, ICH guidelines, and global regulations
Skills Required for this Pharmacy Job
- Strong knowledge of pharmacovigilance and safety reporting
- Safety database handling and case processing skills
- Attention to detail and high data accuracy
- Strong written and verbal communication skills
- Ability to work independently and in cross-functional teams
- Proficiency in MS Word, Excel, PowerPoint, Outlook, and safety systems
- Good organizational and time-management skills
Why This Job Role?
This Pharmacy Job role offers exposure to global pharmacovigilance operations, hands-on experience with ICSR processing and regulatory reporting, and the flexibility of a remote work model. It is ideal for professionals seeking long-term growth in clinical safety and drug vigilance within a globally recognized organization. Graduates seeking Pharmacy Jobs or Pharmacist Jobs can apply now.
