Safety & Pharmacovigilance Specialist I – Literature Review
Location: Hyderabad, India
Employment Type: Full-Time
Job ID: 25104540
Last Updated: December 23, 2025
Experience Required: Minimum 2+ Years
Industry: Pharmacovigilance | Drug Safety | Clinical Research
Job Overview
Syneos Health, a leading global biopharmaceutical solutions organization, is seeking a Safety & Pharmacovigilance Specialist I (Literature Review) to support literature surveillance, case processing, and regulatory-compliant safety reporting across clinical and post-marketing programs.
This role is ideal for pharmacovigilance professionals with experience in literature review, ICSR processing, MedDRA coding, and safety databases, who are looking to grow within a globally recognized CRO environment.
Key Responsibilities
Pharmacovigilance & Safety Operations
Enter, track, and maintain Individual Case Safety Reports (ICSRs) within PVG quality and safety databases.
Support ICSR processing, triage, and evaluation in compliance with SOPs, project-specific safety plans, and global regulatory requirements.
Assess safety data for accuracy, completeness, and reportability.
Perform medical coding for adverse events, medical history, concomitant medications, and laboratory data using MedDRA.
Develop clear and compliant case narratives and manage follow-ups to resolve safety queries within defined timelines.
Assist in the preparation and submission of expedited safety reports as per regulatory guidelines.
Literature Review & Regulatory Activities
Conduct literature screening and safety review from scientific sources to identify reportable safety information.
Support drug dictionary maintenance, drug coding, and MedDRA-related activities.
Validate and submit xEVMPD product records, including accurate coding of indication terms.
Perform manual recoding of product and substance terms arising from ICSRs.
Identify, track, and manage duplicate case reports.
Contribute to SPOR / IDMP activities as required.
Quality, Compliance & Documentation
Perform quality review of ICSRs to ensure consistency and regulatory compliance.
Ensure timely filing of safety documentation within the Trial Master File (TMF) and Pharmacovigilance System Master File for clinical and post-marketing programs.
Maintain compliance with SOPs, Work Instructions, ICH-GCP, GVP, and applicable global safety regulations.
Participate in internal and external audits and inspections.
Apply Syneos Health safety regulatory intelligence to all reporting activities.
Collaboration & Professional Conduct
Build and maintain effective working relationships with internal teams and external stakeholders.
Demonstrate the ability to work independently while contributing effectively within cross-functional teams.
Education & Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or an equivalent combination of education and relevant experience.
Registered Pharmacist or Registered Nurse qualifications are acceptable.
Experience Requirements
Minimum 2+ years of hands-on experience in Pharmacovigilance Literature Review.
Candidates with combined experience in Literature Case Processing and Clinical Trial Case Processing will be preferred.
Prior exposure to Drug Safety Triage Databases is an advantage.
Required Skills & Competencies
Strong knowledge of safety databases, pharmacovigilance workflows, and medical terminology.
Understanding of clinical trial processes (Phases II–IV) and post-marketing safety requirements.
Working knowledge of ICH-GCP, GVP, and global pharmacovigilance regulations.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and shared collaboration tools.
Excellent written and verbal communication skills.
High attention to detail with strong organizational and time management abilities.
Why Join Syneos Health
Work with a global organization supporting 94% of FDA-approved novel drugs and 95% of EMA-authorized products.
Be part of a diverse, inclusive, and patient-centric workplace culture.
Access structured career development, therapeutic training, and long-term growth opportunities in pharmacovigilance and drug safety.
SEO & GEO Optimized Keywords
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