Safety & PV Specialist I – Literature Review | Pune, India
Location: Pune, India
Employment Type: Full-Time
Job ID: 25104540
About the Role
Syneos Health® is a global leader in integrated biopharmaceutical solutions, seeking a Safety & Pharmacovigilance (PV) Specialist I with expertise in literature review. This role involves evaluating, coding, and processing safety data from scientific literature and clinical trials, supporting ICSR processing, safety signal detection, and risk assessment.
The position is ideal for candidates with 2+ years of experience in literature review within pharmacovigilance and familiarity with clinical trial case processing or literature case processing.
Key Responsibilities
Literature & Safety Data Management
Perform literature screening and review for safety and pharmacovigilance purposes.
Enter and track data in safety databases (PVG or equivalent), ensuring completeness and regulatory compliance.
Code events, medical history, concomitant medications, and lab tests using MedDRA and maintain drug dictionaries.
Conduct validation and submission of xEVMPD product records, including coding of indication terms.
Identify and manage duplicate ICSRs and perform quality review of cases.
Assist in query resolution and preparation of narrative summaries for safety reports.
Clinical & Regulatory Compliance
Ensure all relevant documents are filed in the Trial Master File (TMF) and Pharmacovigilance System Master File as per SOPs.
Maintain knowledge and compliance with SOPs, WIs, GCP, ICH guidelines, GVP modules, and global safety regulations.
Support audits and inspections as required, applying regulatory intelligence to daily activities.
Collaboration & Reporting
Work closely with clinical, safety, and data management teams to ensure accurate and timely reporting.
Maintain constructive professional relationships with internal and external stakeholders.
Assist in the development and implementation of safety processes and improvement initiatives.
Required Qualifications & Experience
Education:
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or equivalent.
Experience:
Minimum 2+ years of pharmacovigilance experience with emphasis on literature review.
Experience in literature case processing and clinical trial case processing preferred.
Familiarity with Drug Safety Triager database or equivalent safety database systems.
Skills & Competencies:
Strong understanding of clinical trial phases II–IV and post-marketing safety requirements.
Knowledge of ICH GCP, GVP, and global pharmacovigilance regulations.
Proficient in MS Office Suite (Word, Excel, PowerPoint), Visio, Outlook, and TeamShare.
Excellent communication, interpersonal, and organizational skills.
Detail-oriented, with ability to prioritize multiple tasks and meet deadlines.
Ability to work independently and collaboratively within a team environment.
Why Join Syneos Health
Contribute to high-impact pharmacovigilance and safety initiatives supporting clinical development.
Work in a global, collaborative environment across 110+ countries.
Benefit from career development, mentorship, and peer recognition programs.
Be part of a culture that values diversity, inclusion, and employee growth.
About Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization with 29,000 employees worldwide. We accelerate clinical development and commercial outcomes by uniting clinical, medical affairs, and commercial expertise, providing a platform for professional growth and scientific impact.
Apply Now
Join Syneos Health as a Safety & PV Specialist I (Literature Review) and contribute to global pharmacovigilance operations, literature review, and safety signal assessment while advancing your career in a dynamic biopharmaceutical environment.
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