Senior Director, Drug Safety Avanir Pharmaceuticals
THIS JOB HAS EXPIRED POSITION DETAILS
The Senior Director, Drug Safety position encompasses a key role in setting and executing on departmental strategy, as well as leading the day-to-day functioning of the Drug Safety department. Oversees all departmental activities associated with both investigational and marketed products. The incumbent is also responsible for keeping upper management informed of safety issues and may represent Avanir at internal and external meetings. This position will work and collaborate with colleagues from Clinical Operations, Regulatory & QA, Medical Affairs, Commercial, IT, Finance and Legal.
ESSENTIAL JOB FUNCTIONS
Leads the Drug Safety Department including the medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event reports
Work to ensure regulatory compliance with all aspects of safety reporting.
Responsible for the Medical evaluation of all other relevant safety information including that from clinical trials, scientific literature, and non-clinical studies for on-going surveillance and signal detection.
Oversees and provides medical review of aggregate safety reports. Provides Clinical Expert Statements and other documents related to Pharmacovigilance
Prepares responses to regulatory agency inquiries regarding product safety, benefit-risk relations and risk management.
Provides ongoing benefit-risk evaluation for ongoing clinical trials.
Serve as medical expert for internal functions
Identifies and evaluates potential safety signals
Provides medical expertise and recommendations
Communicates effectively and efficiently on safety and benefit-risk issues to internal / external stakeholders groups.
Serves as a medical expert on the safety profile and appropriate risk minimization measures to risk management plans.
Works closely with internal company staff from different departments including Research and Development, Medical Affairs, Regulatory, Commercial, Compliance and Legal.
Participates in internal and external audits for Drug Safety and Pharmacovigilance as needed.
A minimum of 8-12 years clinical/practical experience in a relevant clinical environment.
A minimum of 2 years of Pharmacovigilance experience in Clinical Safety or Post-Marketing Safety including thorough knowledge of FDA and ICH safety reporting regulations and guidelines.
Experience at a regulatory agency is a plus.
Experience in preparing responses to regulatory agencies on safety-related topics and aggregate analysis of safety data
Professional experience or training in neurology/psychiatry therapeutic area preferred.
Personal leadership, accountability, strong interpersonal and organizational skills, and the ability to work in a cross-functional team environment.
Proven ability to perform in-depth literature research, analysis and interpretation of medical data.
Knowledge of the legal and regulatory guidelines affecting the dissemination of medical information and product promotion
Excellent verbal and written communication skills.
Health care professional (MD)
||101 Enterprise |
Aliso Viejo, CA 92656
THIS JOB HAS EXPIRED