MEDICAL DIRECTOR (DRUG SAFETY AND PHARMACOVIGILANCE)
The Medical Director (Drug Safety Physician) is accountable for comprehensive review and analysis of safety information. This position is responsible for performing safety case report review and other pharmacovigilance related activities in accordance with FDA regulations, ICH guidelines and applicable SOPs. In collaboration with the other departments, ensures effective management and communication of the benefit/risk profile of the product. Neurocrine has a smaller, entrepreneurial environment, and offers the opportunity to have broader involvement in many activities.
ESSENTIAL DUTIES AND RESPONSIBILITIES include, but are not limited to:
Performs medical review of individual case safety reports (clinical and post-marketed) including summarization, coding, seriousness, expectedness and Company causality assessment of investigational and/or marketed products.
Performs aggregate safety data review and interpretation to support safety evaluations.
Ensures accurate and timely review and completion of periodic safety reports (eg, DSUR, IND Annual Report, PADER, PBRER, PSUR, etc.) ;includes authoring and/or reviewing relevant sections of the report.
Provides medical input into safety signal management activities (detection and assessment) of Company products, with reporting of findings to broader team and senior management.
Provides medical contribution and performs medical review of submissions to regulatory authorities and IRBs.
Participate in safety surveillance activities, safety process and convention development, supervision and management of relationships with vendors/CROs and external partners.
Participate in multidisciplinary teams at Neurocrine involving R & D project teams, clinical project managers, business management, regulatory, and others to execute clinical trials, assess new product opportunities, develop clinical research strategy and product development plans depending on need and candidate prior experience.
Minimum of 3 years of experience in pharmacovigilance in a pharmaceutical (preferably) or biotechnology company.
Knowledge of international regulatory authority regulations (especially FDA and EU/EEA).
Strong experience in individual safety case report processing, including triage, medical review, safety data summarization and analysis.
Knowledge of pre- and post-marketing drug safety standards.
Proficiency with safety databases (ARISg preferred) and safety coding dictionaries (eg, MedDRA, WHODRUG).
Experience in clinical research and study protocol development preferred.
Excellent oral and written communication skills required.
Excellent teamwork and interpersonal skills are required.
EDUCATION and/or EXPERIENCE:
M.D. degree plus accredited residency in relevant clinical specialty (eg, Internal Medicine, Family Practice, Pediatrics). Board certification and minimum of 2 years of clinical experience highly desired.