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Safety & Pv Specialist I

1-3 years
5-8 LPA
10 Aug. 6, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.