Primary Responsibilities
As a medical reviewer
- Conduct review and assessment of individual case safety reports obtained from clinical trials, spontaneous and solicited reports
- Determine regulatory reportability of cases obtained from clinical trials, spontaneous and solicited reports within assigned therapeutic team and across all products/sites, as necessary, and in a timely fashion
- Perform triage of cases and determine seriousness and relatedness across products as assigned
- Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labeling, review narrative.
- Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas
- Escalate complex case issues on client product(s) to the medical review team of the client as appropriate
- Conduct assessment of litigation cases across products as assigned
- Identify and resolve case issues, coordinate with client therapeutic teams/site for specific products or functional groups
- Communicate and interact effectively within and across all client therapeutic teams, and within functional team management as appropriate
- Acquire and maintain knowledge of applicable Global Health Authority regulations
- Perform any other drug safety related activities as assigned
Specialized knowledge and skills:
- Proven experience in customer handling and relationship.
- Proven ability to perform task management.
- Proven people management skills.
- Must have good presentation skills and the ability to give presentations.
- Knowledge of the Life Sciences Industry and life cycle of drug.
- Relevant product and industry knowledge
Secondary Responsibilities
- robust competence with medical and therapeutic terminology
- Understanding of Patient Safety regulatory obligation
- Good attention to detail
- Ability to deliver within established timelines
- Fluency in Spoken and written English and excellent comprehension
Quali
📌 Medical Safety Physician (Mysuru)
🏢 Clario
📍 Mysuru