Safety & Pv Specialist I - Medical Device & Pqc

SyneosHealth

Gurugram, India
Icsr processing and case management
Product quality complaint case handling
Experience with argus / arisg safety database
Syneos Health is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success and improving patient outcomes

Job Summary

  • Syneos Health is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success and improving patient outcomes.
  • The Safety & Pharmacovigilance Specialist I is responsible for end-to-end ICSR processing, safety data management, regulatory reporting support, and compliance with global pharmacovigilance regulations.
  • The company fosters a Total Self culture that values diversity, career development, and a supportive work environment where employees can authentically be themselves.

Matching Summary

Syneos Health is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success and improving patient outcomes.

Skills & Requirements

Must-have

  • ICSR processing and case management
  • Product Quality Complaint case handling
  • Experience with Argus / ARISg safety database
  • Regulatory reporting and compliance
  • Medical research safety case handling
  • MedDRA coding and adverse event coding

Nice-to-have

  • Collaboration with internal and external stakeholders
  • Audit and inspection readiness support
  • Literature screening and safety review
  • Proficiency in Microsoft Office applications
  • Support for SPOR / IDMP activities

Key Requirements

  • 2.5 – 4 years experience
  • Minimum 1 year handling Product Quality Complaint cases
  • B.Pharm / M.Pharm / PharmD / BDS / BMS / MBBS degree
  • Strong understanding of global pharmacovigilance regulations
  • Experience with clinical trial phases II–IV and post-marketing safety

Work Rights

Not specified

Tailored Resume

Cover Letter