Safety & PV Specialist I – Literature Review | Hyderabad, India
Location: Hyderabad, India
Job 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 and case processing.
The role focuses on evaluating scientific literature, processing ICSRs, and maintaining pharmacovigilance databases to ensure compliance with global safety regulations. This position is ideal for candidates with 2+ years of literature review experience in drug safety, with a preference for those familiar with clinical trial case processing and literature case processing.
You will contribute to safety signal detection, risk assessment, and pharmacovigilance operations supporting clinical development and post-marketing surveillance.
Key Responsibilities
Literature Review & Safety Data Management
Perform literature screening and review for adverse events, coding drugs, and maintaining MedDRA dictionaries.
Enter and track ICSRs in safety databases, ensuring completeness, accuracy, and regulatory compliance.
Conduct manual recoding of un-recoded products and substances, manage duplicates, and support xEVMPD product record submissions.
Assist in quality reviews of ICSRs and generate timely, accurate safety reports.
Clinical & Regulatory Compliance
Maintain compliance with SOPs, WIs, ICH GCP, GVP, and global safety regulations.
Ensure proper documentation in the Trial Master File (TMF) and Pharmacovigilance System Master File.
Participate in audits, inspections, and process improvement initiatives.
Collaboration & Reporting
Work with cross-functional teams including clinical, medical, and safety teams to ensure accurate reporting and data integrity.
Apply regulatory intelligence and contribute to safety signal detection and risk management assessments.
Communicate effectively with stakeholders, providing status updates, query resolutions, and summary reports.
Required Qualifications & Experience
Education:
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or equivalent.
Experience:
Minimum 2+ years of experience in literature review within pharmacovigilance.
Experience in literature case processing and clinical trial case processing is preferred.
Familiarity with Drug Safety Triager database or other PV database systems.
Skills & Competencies:
Strong knowledge of clinical trial processes (Phases II–IV), post-marketing safety requirements, and global PV regulations.
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint), Visio, Outlook, and TeamShare.
Excellent communication, interpersonal, and organizational skills.
Detail-oriented, able to manage multiple tasks, prioritize effectively, and meet deadlines.
Ability to work independently and collaboratively in a fast-paced, matrix environment.
Why Join Syneos Health
Play a key role in global pharmacovigilance operations and literature review initiatives.
Collaborate with a diverse, high-performing team across 110+ countries.
Access to career development programs, technical training, and mentorship.
Work in a culture that promotes authenticity, inclusion, and continuous growth.
About Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization with 29,000 employees worldwide, delivering high-quality clinical development, medical affairs, and commercial solutions.
Over the past five years, we have supported 94% of all novel FDA-approved drugs, 95% of EMA-authorized products, and managed 200+ clinical studies across 73,000 sites.
Apply Now
Join Syneos Health as a Safety & PV Specialist I (Literature Review) and advance your career in drug safety, literature review, and pharmacovigilance operations in a globally recognized organization.
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