Senior Medical Safety Professional

3 days ago

Gandhinagar, Gujarat, India beBeePharmacovigilance Full time ₹ 1,80,00,000 - ₹ 2,40,00,000

**Job Description**

We are seeking a highly skilled Senior Medical Safety Advisor to join our team. As a key member of the pharmacovigilance department, you will be responsible for providing medical expertise in the evaluation of safety data from various sources.

In this role, you will determine the medical and scientific relevance of serious adverse event reports within the context of the product's safety profile. You will also participate in matrix management activities, including the preparation or participation in evaluating safety issues and the preparation of aggregate reports in collaboration with the Post-Marketing Safety Experts and Safety Surveillance Group.

Your responsibilities will include performing medical reviews and clarifications of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs). You will compose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements.

Additionally, you will provide coding reviews of AEs, SAEs, SADRs, past medical history, concomitant medications, or other medical data listings to verify and medically vet clinical data. You will serve as an internal consultant to pharmacovigilance case processing teams on projects being supported.

**Required Skills and Qualifications**

  • MBBS OR MD from an accredited and internationally recognized medical school with a curriculum relevant to general medical education is required.
  • Three plus (3 + years) experience practicing clinical medicine after award of medical degree. Graduate, and/or Residency training is required.
  • Two plus (2+) years of pharmacovigilance experience is required.
  • Sound knowledge of Medicine.
  • In-depth knowledge of applicable global, regional and local clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
  • Knowledge of Pharmacovigilance- ICSR.
  • In-depth knowledge of departmental standard operating procedures (SOPs).
  • Skill in use of multiple safety databases.
  • Adequate Computer skills, especially Microsoft word, excel & PowerPoint.
  • Good communication skills- verbal and written.
  • Ability to establish and maintain effective working relationships with managers, co-workers, investigative site staff, clients and regulatory agency representatives.

**Benefits**

As a Senior Medical Safety Advisor, you will have the opportunity to work on complex safety issues and contribute to the development of safety strategies. You will also have the chance to collaborate with cross-functional teams and build relationships with key stakeholders.

**Others**

If you are a motivated and detail-oriented individual with a passion for pharmacovigilance, we encourage you to apply for this exciting opportunity.

**Medical Licensing Requirements**

A valid medical license, or equivalent, from the country or region in which he/she resides and works is preferred.

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