Safety & PV Specialist I
Updated: August 20, 2025
Location: IND-Gurugram (Hybrid)
Job ID: 25100771
💰 Estimated Salary: ₹5.5 – 8.5 LPA (based on industry averages for Safety & PV Specialist I roles in India with 1–3 years of PV experience)
Description
Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization designed to accelerate customer success. We transform unique clinical, medical affairs, and commercial insights into outcomes that align with the realities of the modern healthcare market.
Our Clinical Development model places the patient and customer at the core of everything we do. With 29,000 employees across 110 countries, we simplify processes, foster collaboration, and innovate continuously to ensure therapies are delivered faster, because Work Here Matters Everywhere.
Why Syneos Health?
Career growth with technical and therapeutic area training.
Supportive and engaged line management.
Peer recognition and rewards program.
Total Self Culture – fostering diversity, authenticity, and inclusivity across the global workforce.
Exposure to global regulatory environments and leading pharmacovigilance practices.
Job Responsibilities
Enter information into PVG quality and tracking systems for ICSR receipt and tracking.
Process Individual Case Safety Reports (ICSRs) per SOPs and project/program-specific safety plans.
Triage ICSRs, assess completeness, accuracy, and regulatory reportability.
Enter ICSR data into safety databases.
Code medical events, history, concomitant medications, and tests (MedDRA).
Compile narrative summaries.
Identify missing information, raise queries, and ensure resolution.
Support timely and accurate expedited regulatory reporting.
Maintain safety tracking for assigned projects.
Perform safety literature screening, drug coding, and dictionary maintenance.
Validate and submit xEVMPD product records with correct coding.
Conduct manual recoding of un-coded product and substance terms.
Identify and manage duplicate ICSRs.
Support SPOR/IDMP-related activities.
Conduct ICSR quality reviews.
Ensure compliance with TMF and Pharmacovigilance System Master File documentation requirements.
Stay updated with SOPs, WIs, ICH-GCP, GVP, and regulatory frameworks.
Build constructive working relationships within project teams (internal & external).
Participate in audits and regulatory inspections as required.
Apply Syneos Health’s regulatory intelligence to safety reporting practices.
Qualifications
Bachelor’s or Master’s degree in Pharmacy, Medicine, Dental, or related healthcare field (B.Pharm, M.Pharm, MBBS, BDS, BMS preferred).
Prior experience in pharmacovigilance and ICSR case processing is advantageous.
Strong medical knowledge and familiarity with terminology.
Proficiency in English (written and spoken).
High attention to detail, strong documentation, and analytical skills.
Ability to work effectively in a collaborative, global team environment.
Additional Information
Hybrid working model (office-based at Gurugram).
Role requires focus on ICSR case processing, MedDRA coding, literature screening, and regulatory compliance.
Tasks may evolve depending on project and client needs.
Summary
The Safety & PV Specialist I (Gurugram) role is a hybrid opportunity ideal for candidates with a healthcare background and prior pharmacovigilance exposure. Responsibilities include ICSR processing, MedDRA coding, narrative writing, literature review, xEVMPD validation, duplicate case management, and regulatory submissions. The role provides exposure to global PV operations, compliance frameworks, and client audits, making it a strong step forward in a pharmacovigilance career.
Gujarat :
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