Job ID: 25100800
Updated: August 20, 2025
Location: Hyderabad, India (Hybrid)
Syneos Health is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success. With 29,000 employees across 110 countries, we bring together clinical development, medical affairs, and commercial insights to deliver innovative and efficient biopharmaceutical solutions.
Our goal is to streamline processes, prioritize patients, and simplify collaboration for both customers and employees.
Career Development – Supportive management, technical training, and clear growth paths.
Inclusive Culture – Emphasis on diversity, authenticity, and belonging through our Total Self culture.
Recognition & Rewards – Peer recognition and competitive rewards program.
Global Impact – Partnered in 94% of Novel FDA Approvals and 95% of EMA-authorized products over the last 5 years.
The Safety & Pharmacovigilance (PV) Specialist I will be responsible for the collection, assessment, and processing of individual case safety reports (ICSRs), ensuring compliance with applicable global regulations and company procedures.
Process ICSRs in accordance with SOPs and project-specific safety plans.
Handle spontaneous report processing (mandatory experience).
Triage ICSRs, ensuring data completeness and accuracy.
Enter case data into safety databases and perform MedDRA coding.
Code medical events, history, medications, and test results.
Compile narrative summaries for safety cases.
Identify and manage queries, ensuring resolution.
Prepare and submit expedited safety reports per regulatory timelines.
Maintain safety tracking systems and quality documentation.
Conduct literature screening and medical coding (e.g., drug dictionary, MedDRA).
Perform xEVMPD validation and submission tasks.
Manage duplicate ICSRs and contribute to SPOR/IDMP-related activities.
Conduct quality review of ICSRs.
Ensure document submissions to Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF).
Stay updated with GCP, ICH, GVP, and global safety regulations.
Participate in audits and apply Syneos Health’s safety reporting intelligence.
Foster positive working relationships with internal and external teams.
Education:
B.Pharm / M.Pharm / BDS / BMS / MBBS
(Note: BSc / MSc candidates are not eligible)
Experience:
1 to 2.5 years of relevant experience in pharmacovigilance (PV)
Spontaneous case processing is mandatory
Skills & Knowledge:
Strong knowledge of medical terminology
Good command of English (written and verbal)
Familiarity with PV databases and safety reporting tools
Attention to detail and data quality
Understanding of global PV regulations
Location: Hyderabad, India
Work Type: Hybrid (Office-based)
Visit: www.syneoshealth.com
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