Job Title: Safety & PV Specialist II (Literature Review)
Updated: October 29, 2025
Location: Gurugram, India
Job ID: 25102422
Company: Syneos Health®
About Syneos Health
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success. We combine clinical, medical affairs, and commercial expertise to deliver innovative outcomes and improve patient lives.
With over 29,000 employees across 110 countries, we are committed to simplifying processes, driving innovation, and maintaining a patient-centric approach in everything we do.
Motto: Work Here Matters Everywhere.
Why Join Syneos Health
Career growth through training, mentorship, and performance development
Supportive leadership and a collaborative team culture
Recognition programs and total rewards for performance
Inclusive “Total Self Culture” encouraging authenticity and diversity
Global opportunities to contribute to meaningful healthcare advancements
Key Responsibilities
Conduct systematic and ad-hoc literature searches in biomedical databases (Embase, PubMed, Medline) for ICSR identification and safety-relevant information.
Extract and summarize critical safety information from identified literature sources.
Develop and validate search strategies for pharmacovigilance activities.
Conduct local literature searches in compliance with regulatory requirements.
Enter and track ICSR information in PVG quality and tracking systems.
Assist in Safety Management Plan (SMP) preparation when required.
Process ICSRs as per SOPs and safety plans:
Triaging and evaluating data for accuracy, completeness, and regulatory reportability
Coding medical terms (events, history, concomitant meds, tests)
Writing narrative summaries
Performing follow-up queries and reconciliation
Supporting timely expedited report submissions per regulatory timelines
Coordinate with Safety Submissions and Data Management teams for reporting and reconciliation.
Ensure submission of documentation to Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF).
Participate in audits/inspections as required.
Maintain compliance with GCP, ICH, GVP, company SOPs, and project-specific procedures.
Required Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related discipline.
Minimum 3+ years of experience in Pharmacovigilance, specifically in Literature Case Review (Global + Local).
Proficiency in identifying NICR (Signal & Aggregate Reports) from literature.
Strong knowledge of GVP Module VI, ICH GCP, and global PV regulations.
Experience with Safety Databases and medical terminology.
Excellent communication and interpersonal skills.
Strong attention to detail, organization, and multitasking ability.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook), Visio, and collaborative tools like TeamShare.
Ability to work independently and collaboratively in a team environment.
Willingness to travel occasionally (up to 5%).
Preferred Qualifications
Postgraduate degree in Health Sciences or Pharmacy.
Strong understanding of clinical trial processes (Phases II–IV) and post-marketing safety.
Prior experience in signal detection, aggregate report review, or safety surveillance is an advantage.
About Syneos Health – Quick Facts
Partnered in 94% of FDA-approved novel drugs and 95% of EMA-authorized products in the past 5 years.
Supported 200+ studies across 73,000 sites and 675,000+ patients globally.
Committed to diversity, inclusion, and continuous innovation in global healthcare.
Additional Information
This job description is not exhaustive and may be updated to reflect evolving company needs. Equivalent experience, education, or skills will be considered. Syneos Health complies with global employment laws and the Americans with Disabilities Act (ADA), offering reasonable accommodations where appropriate.
Summary
The Safety & PV Specialist II (Literature Review) is responsible for the collection, evaluation, processing, and reporting of Individual Case Safety Reports (ICSRs) in compliance with Good Clinical Practice (GCP), Good Pharmacovigilance Practices (GVP), and regulatory requirements for both clinical and post-marketing safety programs.
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