Associate Medical Safety director
On-siteBengaluru, Karnataka, India
Job Summary
Conduct medical reviews and clarifications of trial-related adverse events and post-marketing adverse drug reactions, including narrative content, coding, expectedness, seriousness, and causality. Compose, edit, and medically review Analyses of Similar Events for expedited cases. Provide aggregate reviews of safety information, including clinical data, postmarketing, literature reviews, and observational studies to maintain oversight of a product's safety profile. Serve as an internal consultant to pharmacovigilance case processing teams and lead training activities, audit preparation, and knowledge exchange initiatives. Provide 24-hour medical support as required on assigned projects and act as Lead Safety Physician or additional team support. Maintain awareness of medical safety-regulatory industry developments and participate in signal detection efforts.
Required Qualifications
- Other A medical degree from an accredited and internationally recognized medical school
- Three (3) years experience practicing clinical medicine after award of medical degree
- 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 and Aggregate reports
- 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
- A valid medical license, or equivalent, from the country or region in which he/she resides and works
Desired Qualifications
- Two (2) years of pharma experience
- Or equivalent combination of education, training, and experience in clinical practice, or pharma (practice, or pharmacovigilance, contract research associate etc)
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