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.
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