Job Title: Safety & PV Specialist I – Literature Review
Category: Pharmacovigilance / Drug Safety
Location: Gurugram, India (Remote/On-site flexibility may apply)
Employment Type: Full-Time
Job ID: 25104540
Syneos Health® is a fully integrated biopharmaceutical solutions organization delivering innovative clinical development, medical affairs, and commercial solutions worldwide. With a presence in 110 countries and a workforce of 29,000+ employees, we partner with leading pharmaceutical and biotech companies to accelerate therapy development and bring life-changing medicines to patients.
Our Clinical Development model emphasizes patient- and client-centric approaches, fostering innovation, efficiency, and compliance. Syneos Health offers a diverse and inclusive workplace where unique perspectives are valued, professional growth is encouraged, and collaboration drives excellence.
The Safety & PV Specialist I (Literature Review) will support pharmacovigilance operations by performing literature surveillance, case processing, and safety database management. This role ensures accurate, timely, and regulatory-compliant safety reporting, contributing to patient safety and the integrity of clinical trial and post-marketing data.
Track and process Individual Case Safety Reports (ICSRs) in PVG or relevant safety tracking systems according to SOPs and project-specific safety plans.
Conduct literature screening and review for adverse events, ensuring MedDRA coding compliance and maintenance of the drug dictionary.
Validate and submit xEVMPD product records, including appropriate MedDRA coding of indication terms.
Identify, manage, and resolve duplicate or un-coded ICSRs; perform quality review of ICSRs.
Ensure submission of all relevant documents to the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF) per SOPs.
Apply regulatory intelligence and maintain compliance with GCP, ICH, GVP, and global PV regulations.
Collaborate with clinical, regulatory, and medical safety teams and participate in audits as required.
Contribute to process improvement initiatives and provide input on literature and case processing workflows.
Education: Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or equivalent.
Experience: Minimum 2+ years in literature review; experience in literature case processing and clinical trial case processing is highly preferred.
Technical Skills: Familiarity with Drug Safety Triager databases, PVG or other safety databases, MedDRA coding, and SPOR/IDMP activities.
Strong understanding of clinical trial processes (Phases II–IV) and post-marketing safety requirements.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Visio, Outlook, and collaborative platforms like Team Share.
Excellent communication, interpersonal, and organizational skills.
Ability to work independently and within cross-functional teams, with strong attention to detail and adherence to deadlines.
Work on global pharmacovigilance programs supporting clinical trials and post-marketing safety.
Gain expertise in literature review, ICSR processing, and MedDRA coding across multiple therapeutic areas.
Collaborate with diverse teams and contribute to high-impact safety operations.
Advance your career through continuous learning, technical training, and mentorship programs.
Be part of a global organization committed to patient safety, innovation, and compliance.
Equal Opportunity Employer: Syneos Health is committed to diversity, equity, and inclusion. Candidates with transferable skills are encouraged to apply. Reasonable accommodations are available for individuals with disabilities.
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Auckland |New Zealand :
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Kyiv |Lima Region :
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