Safety & Pharmacovigilance Specialist I
Syneos Health®
Location: Hyderabad, India (Hybrid Work Model)
Job ID: 25100800
Updated: August 20, 2025
Syneos Health is a leading fully integrated biopharmaceutical solutions organization committed to accelerating customer success by delivering clinical, medical affairs, and commercial solutions. With a workforce of 29,000 employees across 110 countries, the company fosters innovation, collaboration, and a culture where employees can be their authentic selves.
The Safety & Pharmacovigilance Specialist I is responsible for processing Individual Case Safety Reports (ICSRs), ensuring quality and compliance with regulatory requirements, maintaining drug safety data, and supporting safety reporting activities. This role requires 1-2.5 years of pharmacovigilance experience and strong medical knowledge.
Process ICSR cases, with emphasis on spontaneous reports.
Enter and track ICSR data in pharmacovigilance databases according to SOPs and safety plans.
Triage and evaluate ICSRs for completeness, accuracy, and regulatory reportability.
Code events, medical history, concomitant medications, and tests using MedDRA.
Compile detailed narrative summaries for ICSRs.
Identify missing information, raise queries, and ensure resolution.
Assist in timely and accurate expedited safety reporting as per regulatory requirements.
Maintain safety tracking for assigned projects.
Perform literature screening and safety reviews.
Maintain and update drug dictionaries and MedDRA coding.
Validate and submit xEVMPD product records; manually recode un-coded product and substance terms.
Identify and manage duplicate ICSRs.
Support SPOR/IDMP-related activities.
Conduct quality reviews of ICSRs.
Ensure all safety documentation is submitted to Trial Master File (TMF) and Pharmacovigilance System Master File as required.
Maintain compliance with SOPs, Work Instructions, GCP, ICH guidelines, and pharmacovigilance standards.
Foster professional relationships within project teams and external partners.
Participate in audits as needed.
Apply regulatory intelligence to safety reporting activities.
B.Pharm / M.Pharm / BDS / BMS / MBBS
(Note: BSc / MSc not eligible)
1 to 2.5 years in Pharmacovigilance (PV)
Mandatory experience in spontaneous ICSR case processing
Strong English communication skills (written and verbal)
Good medical knowledge and understanding of medical terminology
Proficiency in safety databases and pharmacovigilance tools
Location: Hyderabad (Office-based, Hybrid work model)
Job Type: Full-time
Commitment to employee development, training, and career progression
Inclusive culture promoting authenticity and diversity
Collaborative and innovative work environment
Engagement in cutting-edge biopharmaceutical projects worldwide
Job duties are subject to change at the company’s discretion.
Equivalent education or experience may be considered.
The company complies with all relevant labor laws and promotes equal opportunity employment.
Reasonable accommodations available for employees with disabilities.
Candidates interested in this role can apply directly or join the Syneos Health Talent Network for future opportunities.
Learn more: Syneos Health Website
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