Safety & Pharmacovigilance Specialist I – Literature Review
Job Requisition ID: 25104540
Employment Type: Full-Time
Work Mode: Office-Based
Locations: Gurugram | Hyderabad | Pune, India
Experience Required: 2+ Years
Functional Area: Drug Safety | Pharmacovigilance | Literature Review | ICSR Processing
About the Company
Syneos Health® is a leading global biopharmaceutical solutions organization delivering integrated clinical development, medical affairs, and commercial services. With a strong focus on patient safety and regulatory excellence, Syneos Health partners with life sciences organizations worldwide to accelerate the development and delivery of innovative therapies.
Operating across more than 110 countries with a workforce of over 29,000 professionals, Syneos Health fosters a culture of collaboration, inclusion, and scientific rigor.
Role Overview
Syneos Health is hiring a Safety & Pharmacovigilance Specialist I – Literature Review to support global drug safety operations through systematic literature screening, safety case identification, and ICSR processing. This role is ideal for pharmacovigilance professionals with hands-on experience in literature review, safety databases, and regulatory-compliant safety reporting.
The position plays a critical role in ensuring continuous safety surveillance across clinical and post-marketing programs.
Key Responsibilities
Literature Review & Safety Surveillance
Conduct systematic literature screening to identify safety-relevant cases
Extract, assess, and document adverse event data from scientific publications
Support literature case processing and safety signal identification
ICSR Processing & Quality Activities
Perform ICSR triage and data entry in pharmacovigilance safety databases
Evaluate case data for completeness, accuracy, and regulatory reportability
Code adverse events, medical history, concomitant medications, and tests using MedDRA
Compile high-quality narrative summaries and manage follow-up queries
Identify and manage duplicate ICSRs
Regulatory Compliance & Data Management
Support expedited and periodic safety reporting in accordance with global regulations
Perform quality review of ICSRs and maintain safety tracking metrics
Validate and submit xEVMPD product records with appropriate MedDRA coding
Support SPOR / IDMP-related activities
Ensure accurate filing of safety documentation in TMF and Pharmacovigilance System Master File
Collaboration & Continuous Compliance
Maintain compliance with SOPs, Work Instructions, ICH-GCP, GVP modules, and global safety regulations
Participate in audits and inspections as required
Foster effective collaboration with cross-functional internal and external stakeholders
Education & Experience Requirements
Education:
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or equivalent scientific discipline
Equivalent education and relevant experience will be considered
Experience:
Minimum 2+ years of experience in pharmacovigilance literature review
Experience in literature case processing and clinical trial case processing preferred
Prior exposure to Drug Safety Triager databases is an advantage
Technical & Professional Skills
Hands-on experience with pharmacovigilance safety databases
Strong knowledge of medical terminology and MedDRA coding
Understanding of clinical trial phases (II–IV) and post-marketing safety requirements
Familiarity with ICH-GCP, GVP, and global pharmacovigilance regulations
Proficiency in MS Office (Word, Excel, PowerPoint), Outlook, and collaboration tools
Strong attention to detail with high accuracy standards
Excellent written and verbal communication skills
Ability to manage multiple priorities in a regulated environment
Why Join Syneos Health
Opportunity to work on global safety programs supporting innovative therapies
Strong learning environment with structured training and career progression
Exposure to international regulatory standards and cross-functional teams
Inclusive, science-driven workplace culture
Equal Opportunity Statement
Syneos Health is an equal opportunity employer committed to diversity, inclusion, and compliance with all applicable employment regulations.
Apply now on thepharmadaily.com to advance your career in Pharmacovigilance, Drug Safety, and Scientific Literature Review.
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