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Safety Pv Specialist Ii/ Principal Pv Spl (Contract Role, Mumbai)

2+ years
₹8,00,000 – ₹14,00,000 per annum
10 Aug. 13, 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 II / Principal PV Specialist (Contract) – Mumbai
Location: Mumbai, India (On-site – Client Location)
Salary: Competitive contract-based compensation, typically ₹8,00,000 – ₹14,00,000 per annum for experienced Pharmacovigilance Specialists in Mumbai

Syneos Health is hiring an experienced Safety PV Specialist II / Principal PV Specialist for a contract role based at the client site in Mumbai. This position offers a competitive package and the opportunity to work with one of the leading global biopharmaceutical solutions providers. You will play a critical role in ensuring patient safety by performing advanced pharmacovigilance (PV) activities, from case processing to safety reporting, in compliance with GCP, GVP, and regulatory requirements.

Responsibilities:

  • Collect, process, and report Individual Case Safety Reports (ICSRs) from clinical trials and post-marketing safety programs.

  • Conduct literature screening and review for safety data.

  • Perform drug coding and maintain drug dictionaries.

  • Code medical terms using MedDRA and manage product dictionary updates (xEVMPD).

  • Identify and manage duplicate ICSR cases.

  • Perform data cleaning, validation, and quality review of ICSRs, substances, products, and organizations.

  • Execute SPOR/IDMP-related pharmacovigilance activities.

  • Prepare expedited and periodic safety reports in accordance with global PV regulations.

  • Ensure compliance with data privacy, GCP, GVP, and project-specific SOPs.

Required Skills & Qualifications:

  • Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Medicine, or related field.

  • Extensive experience in pharmacovigilance case processing and safety data management.

  • Proficiency in MedDRA coding, drug safety databases, and regulatory PV guidelines.

  • Strong knowledge of GVP, ICH-GCP, and global PV compliance requirements.

  • Familiarity with xEVMPD and IDMP activities.

  • Exceptional attention to detail and ability to meet strict deadlines.

  • Strong written and verbal communication skills in English.

Perks & Benefits:

  • Competitive contract salary with potential for renewal.

  • Exposure to global pharmacovigilance operations and regulatory requirements.

  • Opportunity to work with cutting-edge safety systems and methodologies.

  • Collaborative work environment with supportive leadership.

About Syneos Health:
Syneos Health® is a global, fully integrated biopharmaceutical solutions organization with operations in over 110 countries and 29,000 employees. Partnering with top pharmaceutical and biotech companies, Syneos Health accelerates the development and delivery of life-changing therapies. The company has supported 94% of all novel FDA-approved drugs in the last five years, making it a trusted leader in drug safety and regulatory compliance.

Work Mode: On-site (Client Location – Mumbai, India)

Join Syneos Health’s pharmacovigilance team and help ensure the safety of therapies that impact patients worldwide. Apply now to contribute your expertise in drug safety to a global leader in healthcare innovation.