Safety & Pharmacovigilance Specialist I – Literature Review
Location: Gurugram, 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 hiring a Safety & Pharmacovigilance Specialist I (Literature Review) to support end-to-end safety surveillance activities across clinical trials and post-marketing programs.
This role is ideal for professionals with hands-on experience in literature review, ICSR processing, and safety databases, who are looking to grow their career within a global pharmacovigilance environment.
Key Responsibilities
Pharmacovigilance & Case Processing
Enter and maintain safety data in PVG quality and tracking systems for Individual Case Safety Reports (ICSRs).
Assist in processing, triaging, and evaluation of ICSRs in accordance with SOPs, project-specific safety plans, and regulatory requirements.
Assess ICSR data for completeness, accuracy, and reportability.
Perform medical coding for adverse events, medical history, concomitant medications, and laboratory tests using MedDRA.
Compile high-quality narrative summaries and follow up on safety queries until resolution.
Literature Review & Signal Support
Conduct literature screening and review to identify safety-relevant information.
Perform drug coding, maintain drug dictionaries, and support MedDRA coding activities.
Identify and manage duplicate ICSRs.
Support SPOR / IDMP activities, including validation and submission of xEVMPD product records.
Perform manual recoding of un-recoded product and substance terms arising from ICSRs.
Quality & Compliance
Perform quality review of ICSRs to ensure regulatory compliance.
Ensure timely submission of safety documentation to the Trial Master File (TMF) and Pharmacovigilance System Master File, as applicable.
Maintain strict adherence to SOPs, Work Instructions, ICH-GCP, GVP, and global safety regulations.
Participate in internal and external audits and inspections as required.
Apply regulatory intelligence to safety reporting activities.
Collaboration & Communication
Foster effective working relationships with cross-functional internal and external stakeholders.
Maintain accurate safety tracking and reporting for assigned activities.
Work independently while contributing effectively within a team environment.
Education & Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or an equivalent combination of education and experience.
Registered Pharmacist or Registered Nurse qualifications are acceptable.
Experience Requirements
Minimum 2+ years of experience in Literature Review within Pharmacovigilance or Drug Safety.
Candidates with combined experience in Literature Case Processing and Clinical Trial Case Processing are strongly preferred.
Prior experience with Drug Safety Triage Databases is desirable.
Required Skills & Knowledge
Strong knowledge of safety databases, medical terminology, and pharmacovigilance workflows.
Understanding of clinical trial phases (II–IV) and post-marketing safety requirements.
Working knowledge of ICH-GCP, GVP, and global drug safety regulations.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and shared collaboration tools.
Excellent written and verbal communication skills.
High attention to detail with the ability to manage multiple tasks and deadlines efficiently.
Why Join Syneos Health
Work with a global organization involved in 94% of FDA-approved novel drugs and 95% of EMA-authorized products.
Be part of a collaborative, inclusive, and patient-focused culture.
Access structured career development, technical training, and global exposure in pharmacovigilance.
SEO & GEO Targeted Keywords
Safety & PV Specialist jobs India, Pharmacovigilance Literature Review jobs, Drug Safety Specialist Gurugram, PV ICSR Processing roles, Clinical Safety jobs India, Syneos Health careers, Pharmacovigilance jobs Gurgaon.
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