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Senior Medical Safety Specialist

2 weeks ago

Dombivli, Maharashtra, India beBeeMedical Full time ₹ 25,00,000 - ₹ 35,00,000

Role:

A seasoned expert in pharmacovigilance is required to conduct medical reviews and clarifications of trial-related adverse events (AEs) and post-marketing adverse drug reactions (ADRs).

Key Responsibilities:
  • Conduct thorough medical assessments of AEs and SAEs, including past medical history and concomitant medications.
  • Compose, edit, and medically review analyses of similar events (AOSE) for expedited cases as appropriate based on regulatory requirements.
  • Verify and vet clinical data by reviewing coding of AEs, SAEs, SADRs, and other medical data listings.
  • Collaborate with internal teams to provide guidance on projects supported.
  • Perform safety reviews of protocols, Investigative Brochures, and/or Case Report Forms (CRFs) for appropriate safety content and data capture.

Qualifications:

  • MBBS or MD from an accredited and internationally recognized medical school with a relevant curriculum.
  • Three plus years of experience practicing clinical medicine after award of medical degree, including graduate and/or residency training.
  • Two plus years of pharmacovigilance experience required.
  • Sound knowledge of medicine and global, regional, and local clinical research regulatory requirements.
  • In-depth knowledge of applicable guidelines, such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH).
  • Knowledge of Pharmacovigilance- ICSR.
  • Departmental standard operating procedures (SOPs) expertise.
  • Proficiency in use of multiple safety databases.
  • Adequate computer skills, especially Microsoft Word, Excel & PowerPoint.
  • Strong communication and relationship-building skills.