Life Sciences Job at Syneos | Apply Now For Safety & PV Specialist Role
Join Syneos Health, a leading biopharmaceutical solutions organization, as a Safety & PV Specialist I. This critical position involves executing pharmacovigilance (PV) activities to ensure timely and accurate reporting of safety data globally. If you have a background in life science and are looking for a high-impact life sciences job that offers robust development and progression, this is an excellent Syneos career opportunity. Collaborate with passionate problem solvers to accelerate the delivery of therapies worldwide.
- Designation: Safety & PV Specialist I
- Job Requisition ID: 25102730
- Locations: Gurugram, Hyderabad, Pune
About The Company
Syneos Health® is a fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. Our Clinical Development model is patient-centric, focusing on streamlining work and innovating as a team. With over 29,000 employees across 110 countries, we emphasize developing our people through career progression, technical training, and a Total Self culture where diversity of thought creates an environment where everyone belongs. Your Syneos career will contribute to working with industry leaders: over the past 5 years, we’ve partnered with 94% of all Novel FDA Approved Drugs.
Key Responsibilities
This specialized life sciences job requires
the candidate to maintain high standards of quality and regulatory compliance in safety data management:- ICSR Processing: Triage, process, and track Individual Case Safety Reports (ICSRs) in the safety database.
- Data Quality: Evaluate ICSR data for completeness and accuracy; code events, medications, and medical history using established dictionaries (MedDRA).
- Narrative & Query: Compile complete narrative summaries and identify information to be queried, managing follow-up until satisfactory resolution.
- Regulatory Reporting: Assist in generating timely, consistent, and accurate expedited reports according to applicable global regulations (GCP, ICH guidelines, GVP).
- Documentation: Ensure all relevant documents are submitted to the Trial Master File (TMF) and the Pharmacovigilance System Master File (PSMF).
- Compliance: Perform drug coding, literature screening, maintenance of drug dictionaries, and activities related to SPOR/IDMP and xEVMPD product records.
Essential Qualifications and Expertise
Success in this Syneos career requires specialized knowledge in clinical trial processes and safety regulations:
Essential Qualifications
- Education: Bachelor’s Degree in Life Science, or an equivalent combination of education and experience.
- Technical Knowledge:
- Required knowledge of Safety Database systems and medical terminology.
- Good understanding of ICH GCP, GVP, and regulations related to Safety and Pharmacovigilance.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and internet tools.
Key Competencies
- Excellent communication and interpersonal skills (written and spoken).
- Good organizational skills with proven ability to prioritize and manage multiple tasks and projects.
- Detail oriented with a high degree of accuracy and ability to meet deadlines.
- Ability to work independently and collaboratively in a team environment.
This Syneos career opportunity as a Safety & PV Specialist I is ideal for entry to mid-level professionals seeking a robust life sciences job in Pharmacovigilance. If you are detail-oriented, knowledgeable in GVP/GCP, and ready to collaborate on accelerating therapy delivery, secure your place in this vital Syneos Health team by applying before the December 31, 2025, deadline.
