PHARMA BHARAT
PHARMACEUTICAL JOB PORTAL
No new notifications

Advertisement

Safety Specialist I & PV Specialist II at Syneos Health

Published on

If you’re looking for a pharmacovigilance career in India, Syneos Healthโ€”one of the worldโ€™s leading clinical research and biopharmaceutical organizationsโ€”is now hiring for two exciting full-time office-based positions:

  • Safety Specialist I โ€“ Hyderabad
  • Safety & PV Specialist II (Literature Review) โ€“ Hyderabad / Gurugram

These roles offer a great opportunity to work on global drug safety operations, exposure to ICH-GCP, GVP, ICSRs, MedDRA coding, and real-world safety databases while growing your PV career.

Advertisement

๐Ÿงช Role 1: Safety Specialist I โ€“ Hyderabad

Key Responsibilities

  • Process and track Individual Case Safety Reports (ICSRs)
  • Perform MedDRA coding, narrative writing, and query resolution
  • Literature screening and drug coding
  • Validate & submit xEVMPD product records
  • Identify duplicate ICSRs and ensure regulatory reporting compliance
  • Ensure proper documentation in Trial Master File (TMF)
  • Support audits and maintain compliance with SOPs, GVP, ICH-GCP

Required Qualifications

  • Bachelorโ€™s degree in Life Sciences, Pharmacy, Nursing, or equivalent
  • Understanding of pharmacovigilance regulations and safety reporting
  • Knowledge of Safety Databases, MedDRA, GCP, GVP
  • Strong communication, attention to detail & organizational skills

๐Ÿงช Role 2: Safety & PV Specialist II (Literature Review)

๐Ÿ“ Location: Hyderabad or Gurugram

Key Responsibilities

  • Conduct global and local literature searches (Embase, PubMed, Medline)
  • Extract and summarize safety-relevant data from publications
  • Process literature-driven ICSRs and write narrative summaries
  • Validate search strategies aligned with GVP Module VI
  • Support audit readiness and TMF documentation compliance
  • Collaborate with data management teams for reconciliation

Required Qualifications

  • Bachelorโ€™s/PG in Pharmacy, Life Science, Nursing, or equivalent
  • Minimum 3.5+ years of pharmacovigilance experience
  • Strong experience in literature review for safety case processing
  • Mandatory knowledge of GVP Module VI

๐Ÿ’ผ Why Join Syneos Health?

  • Career growth and mentorship
  • Global project exposure
  • Total Rewards Recognition Program
  • Supportive and diverse work culture
  • Opportunity to work on FDA & EMA submissions

๐Ÿ“ Job Locations

RoleLocationType
Safety Specialist IHyderabadOffice-based
Safety & PV Specialist IIHyderabad / GurugramOffice-based

๐Ÿ“ How to Apply

Application Link for Safety Specialist I โ€“ Hyderabad

Application Link for Safety & PV Specialist II (Literature Review)

Share This Job

โœ… Job Details Copied!