Associate Medical Safety Director

We are looking for an Associate Medical Safety Director to provide medical, scientific and therapeutic expertise on pharmacovigilance services. Participates in all aspects of the Medical Safety activities as per scope of work, such as performing medical review and clarification of trial-related Adverse Events including review of analysis of similar events, medical evaluation of post-marketing adverse drug reactions, review medical inputs for into signal management and benefit-risk evaluation of drugs in clinical trial and post marketing set up, safety aggregate report review, safety review of study protocol, investigators brochure and other reference safety information, clinical study report narrative review, providing medical assessment comments and serving as an internal consultant for any medical support for pharmacovigilance operations.

Associate Medical Safety Director

Role responsibilities:

• You will be performing medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality, and company summary
• Composing, editing, and medically reviewing Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements
• Serving as an internal consultant to pharmacovigilance case processing teams on projects.
• Providing aggregate reviews of safety information, including clinical data, to maintain oversight of a product’s safety profile
• Providing coding review of AEs, Past medical history, Concomitant medications, or other medical data listings to verify and medically vet clinical data
• Representing safety and clinical data review findings during client meetings
• Providing medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports
• Providing medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies
• Providing medical oversight for label development, review, and change
• Providing medical support and attendance at Data Safety Monitoring Board Meetings
• Attending and contributing to medical safety evaluation on Safety Monitoring Committees

Do you have the skills, experience and qualification required for the role:

• A medical degree from an accredited and internationally recognized medical school
• Around three years of clinical practice experience with two additional years in the pharmaceutical or associated industry
• Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice
• Knowledge of clinical trials and pharmaceutical research process
• Experience in Risk management, Signal detection and Aggregate reports.
• Ability to establish and meet priorities, deadlines, and objectives
• Demonstrated skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients