Syneos Health, a global leader in biopharmaceutical solutions, is seeking a Safety & PV Specialist I for their Gurugram office (Hybrid work). This is an exciting opportunity for life sciences graduates, pharmacists, or registered nurses to advance their career in pharmacovigilance (PV) and drug safety. The role involves literature searches, ICSR management, regulatory compliance, and supporting clinical trials across phases II-IV and post-marketing safety programs.
If you are detail-oriented, proactive, and passionate about patient safety, this position will allow you to work in a dynamic, collaborative environment with a global impact.
Key Responsibilities
- Conduct systematic and ad-hoc literature searches in biomedical databases like Embase, PubMed, and Medline for ICSR identification and safety information.
- Extract, summarize, and validate key safety data from literature sources.
- Develop and validate search strategies for pharmacovigilance purposes.
- Conduct local literature searches and review in compliance with global and local regulatory requirements.
- Enter and track ICSR data in PVG quality and tracking systems.
- Triage ICSRs, verify completeness, accuracy, and regulatory reportability.
- Perform medical coding (events, history, concomitant medications) and narrative summaries.
- Manage duplicate ICSRs, SPOR/IDMP activities, and xEVMPD product record validation.
- Support timely submission of expedited safety reports per regulatory requirements.
- Maintain compliance with SOPs, GCP, ICH guidelines, GVP, and local/global regulations.
- Participate in audits, foster professional relationships, and apply regulatory intelligence in daily tasks.
Qualifications
- Bachelor’s degree in Life Sciences, Registered Nurse, or Pharmacist. Equivalent experience may be considered.
- Strong knowledge of safety databases, medical terminology, and ICSR processing.
- Understanding of clinical trials (Phases II-IV) and post-marketing safety requirements.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Visio, Outlook, Teams, and shared workspaces.
- Excellent written and verbal communication skills, attention to detail, and organizational abilities.
- Ability to work independently and collaboratively in a hybrid environment.
Benefits
- Opportunity to work with a global leader in biopharmaceutical solutions.
- Career development and technical training in pharmacovigilance and drug safety.
- Supportive and inclusive Total Self culture fostering diversity and growth.
- Exposure to global clinical trials and post-marketing safety programs.
- Competitive compensation package (INR 7–12 LPA approximate for entry-level PV roles).
How to Apply
