A position is available for a Medical Director-Safety in a pharmaceutical company in New Jersey.
The Medical Director-Safety will be responsible for evaluating the safety of drugs, either under development or marketed, and ensure effective reporting of findings throughout the corporation. Incumbent will also be responsible for ensuring the integrity of safety data, rendering appropriate critical milestone recommendations, providing key clinical input for the Global Project Teams as well as for interaction with Health Authorities, and collaborating with key staff throughout the corporation in a consensus-based paradigm. Responsibilities include; mentoring and guiding direct reports in the delegation of activities in Safety, budget management of all activities under his/her jurisdiction, effective management of external vendors in the management and evaluation of safety data, provide support, guidance and decision making to clinical, regulatory, marketing and safety teams for safety-related issues, set strategies for development, implementation and maintenance of the adverse event and medical information systems, supervise and mentor the Safety staff regarding gathering, evaluating and processing adverse event reports in compliance with regulations, serve as primary medical reviewer of individual adverse event reports, safety summaries and other documentation, work effectively with other functional areas (data management, regulatory, etc.) and colleagues in Japan and Europe to facilitate the design and execution of clinical trials, provide safety sections for INDs, Annual Reports and NDAs. Assist with preparation of clinical protocols, and provide effective leadership, mentoring, and career development of all direct reports. Qualifications include an MD with training (BC/BE) in Internal Medicine, 2+ years direct pharmacovigilance/drug safety experience, including a thorough knowledge of safety/pharmacovigilance concepts, thorough knowledge of regulatory requirements, hands on scientific/medical knowledge and superior leadership, planning and management skills, and previous supervisory experience is preferred. The successful candidate will be required to take ownership of the safety database for clinical studies and effectively supervise all direct reports and will be asked to work with key opinion leaders and vendors as deemed appropriate and necessary. In addition, the successful candidate will be required to serve as a source of education, mentorship, and guidance to direct reports.
If you are interested in this position, please email your CV and a cover letter to info@PRNresource.com, and we will forward them to the executive recruiter filling this position.
