Principal Safety & Pv Specialist (literature Cp & Review)

Syneos Health

Gurugram, India
Hybrid
Conduct systematic literature searches
Extract and summarize safety information
Create and validate search strategies
Syneos Health is seeking a Principal Safety & PV Specialist to conduct literature searches and manage pharmacovigilance processes. The ideal candidate should have substantial experience in literature case processing, strong communication skills, and a keen understanding of regulatory requirements

Job Summary

  • Conduct systematic and ad-hoc literature searches in global biomedical databases for ICSR identification and safety-relevant information.
  • Prepares Safety Management Plan and is responsible for work allocation, compilation and reporting of program reports on timely basis.
  • Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process.

Matching Summary

Match Score: 85

Syneos Health is seeking a Principal Safety & PV Specialist to conduct literature searches and manage pharmacovigilance processes. The ideal candidate should have substantial experience in literature case processing, strong communication skills, and a keen understanding of regulatory requirements.

Skills & Requirements

Must-have

  • Conduct systematic literature searches
  • Extract and summarize safety information
  • Create and validate search strategies
  • Understand regulatory requirements
  • Process ICSRs according to SOPs
  • Gather information for trend analysis

Nice-to-have

  • Passionate problem solvers
  • Innovating as a team
  • Agile and driven
  • Authentically be yourself
  • Diversity of thoughts

Key Requirements

  • Minimum 8 Years of experience
  • Team lead experience
  • Safety Database systems knowledge
  • Medical terminology knowledge
  • ICH GCP, GVP and regulations knowledge

Work Rights

Not specified

Tailored Resume

Cover Letter