Safety & PV Specialist I
📍 Location: Gurugram, India
🕒 Experience: 1–3 Years
💼 Industry: Pharmacovigilance / Drug Safety
🔍 Job ID: 25003479
📅 Date Updated: 05-Aug-2025
Position Summary:
Syneos Health is looking for a Safety & PV Specialist I to join our growing Pharmacovigilance team. In this role, you will play a crucial part in processing, managing, and reporting adverse events from various clinical and post-marketing sources, supporting global safety compliance standards and enhancing patient safety outcomes.
Key Responsibilities:
Enter and track ICSRs in PVG quality systems.
Process and triage case reports per SOPs and safety protocols.
Evaluate ICSR data for accuracy, completeness, and regulatory reportability.
Code adverse events, medical history, medications, and lab results.
Compile narrative summaries and follow up on incomplete data.
Support regulatory submissions of expedited reports.
Perform literature screening and maintain drug safety dictionaries.
Validate and submit xEVMPD product records; manage SPOR/IDMP tasks.
Identify and manage duplicate cases; perform MedDRA coding.
Conduct quality reviews and ensure timely document submission to TMF and PSMF.
Adhere to GCP, ICH, GVP, and project-specific requirements.
Foster collaboration with cross-functional project teams.
Participate in audits and apply regulatory intelligence to reporting activities.
Required Qualifications & Skills:
Bachelor’s degree in Life Sciences, Pharmacy, or related field.
Knowledge of global pharmacovigilance regulations and processes.
Proficiency in safety databases, MedDRA, and coding standards.
Strong attention to detail, organizational, and communication skills.
Ability to work collaboratively in a fast-paced environment.
💰 Estimated Salary: ₹5 – ₹8 LPA (based on market standards for entry-to-mid-level PV roles in Gurugram)
Why Join Syneos Health?
Work with a global leader supporting 94% of FDA-approved novel drugs.
Access to structured career progression, training, and total rewards.
Inclusive culture focused on authenticity, development, and innovation.
Apply now to be part of a team where work truly matters—everywhere.
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