Safety & Pharmacovigilance Specialist I – Literature Review
Updated: December 23, 2025
Location: Hyderabad, India
Job ID: 25104540
Employment Type: Full-Time
About the Company
Syneos Health® is a global, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success across the clinical development, medical affairs, and commercial continuum. With operations in over 110 countries and a workforce of more than 29,000 professionals, Syneos Health partners with biopharma innovators to bring life-changing therapies to patients worldwide.
Driven by a patient-centric Clinical Development model, Syneos Health continuously streamlines processes, embraces innovation, and fosters a collaborative culture focused on quality, compliance, and impact.
Job Overview
Syneos Health is hiring a Safety & Pharmacovigilance Specialist I (Literature Review) to support global drug safety operations. This role is ideal for professionals with hands-on experience in literature surveillance, ICSR processing, and regulatory safety reporting within clinical trials and post-marketing environments.
The position plays a critical role in ensuring regulatory compliance, accurate safety data management, and timely reporting in accordance with global pharmacovigilance standards.
Key Responsibilities
Perform end-to-end literature screening and safety review to identify reportable adverse events.
Process and triage Individual Case Safety Reports (ICSRs) in compliance with SOPs, project-specific safety plans, and global regulations.
Enter, review, and validate safety data within pharmacovigilance databases, ensuring completeness, accuracy, and regulatory reportability.
Code adverse events, medical history, concomitant medications, indications, and laboratory tests using MedDRA and approved drug dictionaries.
Prepare comprehensive and high-quality case narratives and follow up on missing or incomplete safety information.
Support expedited and periodic safety reporting in accordance with global regulatory timelines.
Identify and manage duplicate ICSRs and perform quality reviews as required.
Support xEVMPD submissions, SPOR/IDMP activities, and product data maintenance.
Ensure timely and accurate filing of safety documentation in the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF).
Maintain compliance with ICH-GCP, GVP, SOPs, WIs, and applicable global drug safety regulations.
Participate in audits, inspections, and internal quality initiatives as required.
Collaborate effectively with cross-functional and global project teams.
Required Qualifications & Experience
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or an equivalent scientific discipline.
Minimum 2 years of experience in pharmacovigilance literature review is mandatory.
Experience in Literature Case Processing and Clinical Trial Case Processing is highly preferred.
Hands-on exposure to Drug Safety Triager databases for literature cases is an advantage.
Strong working knowledge of ICSR processing, MedDRA coding, drug dictionaries, and medical terminology.
Solid understanding of clinical trial phases II–IV, post-marketing safety requirements, ICH-GCP, GVP, and global safety regulations.
Proficiency in Microsoft Office (Word, Excel, PowerPoint) and shared content management tools.
Excellent written and verbal communication skills.
Strong organizational abilities with attention to detail and accuracy.
Ability to work independently as well as collaboratively in a global team environment.
Why Join Syneos Health
Work with a global organization involved in 94% of novel FDA-approved drugs and 95% of EMA-authorized products in recent years.
Access structured career development, therapeutic training, and progression opportunities.
Be part of an inclusive, diverse, and people-first workplace culture.
Contribute to meaningful work that directly impacts patient safety and global healthcare outcomes.
Additional Information
This job description outlines the primary responsibilities of the role; however, duties may evolve based on business needs. Syneos Health is an equal opportunity employer and is committed to compliance with all applicable employment, equality, and accessibility regulations.
Apply Now
Interested candidates are encouraged to apply through thepharmadaily.com.
Not ready to apply? Join the Talent Network to stay updated on future Pharmacovigilance and Drug Safety opportunities.
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