Are you a skilled pharmacovigilance professional looking to advance your career in a globally recognized organization? Syneos Health is hiring a Safety & Pharmacovigilance Specialist II for its offices in Gurugram and Pune. This is an excellent opportunity to join a leading biopharmaceutical solutions organization and contribute to accelerating customer success in the healthcare industry.
Job Details
- Job Title: Safety & Pharmacovigilance Specialist II
- Location: Gurugram / Pune, India
- Job ID: 25002009
- Updated: Today
About Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. With a workforce of 29,000 employees across 110 countries, Syneos Health is committed to translating clinical, medical affairs, and commercial insights into actionable outcomes.
The company’s Clinical Development model places the customer and patient at the center of everything they do. Syneos Health fosters a Total Self culture, where employees are encouraged to bring their authentic selves to work. This inclusive environment promotes diversity of thoughts, backgrounds, and perspectives, ensuring everyone feels they belong.
Over the past five years, Syneos Health has collaborated on 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 studies across 73,000 sites and 675,000+ trial patients.
Job Description
As a Safety & Pharmacovigilance Specialist II, you will play a critical role in ensuring the safety and compliance of pharmaceutical products. Your responsibilities will include:
Key Responsibilities
- Enter and track ICSR (Individual Case Safety Report) information into PVG quality and tracking systems.
- Assist in preparing project plans such as the Safety Management Plan.
- Process ICSRs in compliance with Standard Operating Procedures (SOPs) and project-specific safety plans.
- Triage ICSRs, evaluate data for completeness, accuracy, and regulatory reportability.
- Enter data into safety databases and code events, medical history, concomitant medications, and tests.
- Compile narrative summaries and resolve queries related to ICSRs.
- Participate in the generation of expedited reports in accordance with regulatory requirements.
- Coordinate with data management teams for reconciliation of safety data.
- Perform literature screening, drug coding, and MedDRA coding as required.
- Validate and submit xEVMPD product records and manage duplicate ICSRs.
- Conduct quality reviews of ICSRs and mentor/train new hires.
- Ensure compliance with ICH GCP, GVP, and other regulatory guidelines.
- Participate in audits/inspections and maintain Trial Master File (TMF) documentation.
Qualifications
To be considered for this role, you should have:
- A Bachelor’s Degree in life sciences, pharmacy, or a related field (e.g., B.Pharm, M.Pharm, BDS, BMS).
- 3-5 years of experience in pharmacovigilance, specifically in ICSR case processing.
- Proficiency in safety database systems like ARGUS and knowledge of medical terminology.
- A strong understanding of clinical trial processes (Phases II-IV) and post-marketing safety requirements.
- Familiarity with Microsoft Office Suite (Word, Excel, PowerPoint), Visio, and Outlook.
- Excellent communication, organizational, and interpersonal skills.
- The ability to work independently and in a team environment while meeting deadlines.
Why Join Syneos Health?
- Career Development: Opportunities for progression and technical/therapeutic training.
- Inclusive Culture: A supportive environment that values diversity and inclusion.
- Global Impact: Work on projects that contribute to the development of life-changing therapies.
- Total Rewards Program: Competitive benefits and recognition programs.
