Executive Director, Drug Safety
Proclinical is currently recruiting for an Executive Director of Drug Safety for a pharmaceutical company located in San Diego, CA. Successful candidate will be responsible for the clinical safety strategy for assigned drug projects and products, provides drug safety expertise and guidance to Clinical Development, Safety Oversight Committee (SOC) and the Clinical Project Teams, and drives proactive implementation of risk management initiatives in accordance with global regulatory requirements.
- Provide support and back-up for Head of Drug Safety and tactical support to the Safety Oversight Committee.
- Perform individual case report assessment and determines regulatory reporting responsibilities as required.
- Provide medical review of case narratives for medical content, accuracy, and signal detection.
- Interpret aggregate safety data for periodic reports and evaluating for potential new signals.
- Lead signal detection, signal evaluation, data analysis, and benefit-risk evaluation for assigned compounds.
- Lead risk management and risk mitigation activities, including medical and safety leadership for RMPs.
- Write individual case assessments and evaluate aggregate safety data for periodic reports as required.
- Provide medical input into identification and utilization of appropriate sources of information and database searches to retrieve relevant data for evaluation of signals.
- Proactively evaluate the clinical implications of safety data from pre-clinical studies, clinical studies, literature, and other information sources in order to predict/establish the safety profile of compounds in clinical development.
- Contribute to the maintenance of the pharmacovigilance system and processes.
- Participate in SOP updates, audits, and inspection readiness.
- Support the medical coding group on an ad hoc basis.
- Participate in writing of white papers and other internal scientific publications.
- Participates in selection and bidding activities for vendors and contractors
Skills and Requirements:
- Medical degree (e.g. MD, MBBS) required.
- 5+ years of clinical experience post-registration.
- High level of medical competence, with an ability to balance this with industry standards to achieve business goals.
- 5+ years of Drug Development/Patient Safety experience (the majority of which should be in industry in Patient Safety) with clear evidence of delivery.
- A thorough knowledge of the pharmaceutical/biopharmaceutical industry, especially clinical research and global regulatory requirements, and practices governing expedited and periodic safety reporting, signal generation, safety evaluation, and risk management activities.
- Able to work across therapeutic areas and functions.
- Works collaboratively (establishes shared purpose across boundaries).
- Develops people and the organization (invests in long-term development of others).
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Yannick Dada at (+1) 646-741-8433 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.