Medical Director/Executive Medical Director – Pharmacovigilance

The Director/Executive Director of Drug Safety is 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. Major areas of responsibility include continuous efficient evaluation of safety data to perform signal evaluation and predict and manage the safety profile of compounds in clinical development, consistent communication of safety topics across all regulatory safety documents, and strategic collaboration with partners. This position reports to the VP and Head of Drug Safety.

RESPONSIBILITIES:

• Provides support and back-up for Head of Drug Safety and tactical support to the Safety Oversight Committee
• Performs individual case report assessment and determines regulatory reporting responsibilities as required
• Provides 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
• Writes individual case assessments and evaluates aggregate safety data for periodic reports as required
• Provides medical input into identification and utilization of appropriate sources of information and database searches to retrieve relevant data for evaluation of signals
• Proactively evaluates 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
• Offers medical judgment on complex safety issues
• Determines the most appropriate monitoring and stopping rules for clinical trial protocols in partnership with the project’s medical monitor
• Presents safety data to DSMBs for assigned products
• Collaborates with partner company’s drug safety team and clinicians, and provisions regular safety summaries
• Contributes to/reviews the Safety Data Exchange Agreements and other documents shared with partners; provides vendor oversight for assigned products
• Participates in cross-functional project teams; communicates across organizational levels and functions
• Contributes to the maintenance of the pharmacovigilance system and processes
• Participates in SOP updates, audits, and inspection readiness
• Writes/updates core safety information for assigned projects
• Writes/reviews and provides technical input for the safety sections of regulatory documents for assigned projects (i.e. protocols, IBs, ICFs, CSRs, IND submissions, annual reports, etc.)
• Prepares and/or reviews safety documents and provides strategic input into responses to regulatory inquiries
• Participates in external regulatory and non-regulatory meetings, including those with consultants and other companies, such as licensing partners
• May assist in due diligence activities
• May provide support to Legal for product liability litigation, as appropriate
• Supports the medical coding group on an ad hoc basis
• Participates in reconciliation procedures
• Guides and/or trains external personnel/parties involved in Company’ clinical studies
• Provide clinical education support for internal company customers
• Collaborates effectively in cross-functional and cross-cultural project teams and environments, and work with external providers
• Maintain clinical and technical expertise in the therapeutic areas in which Company operates (i.e. through review of scientific journals, attendance at scientific and key technical meetings, etc.)
• Participates in writing of white papers and other internal scientific publications
• Assist in accomplishing department and corporate objectives
• May be required to act as medical monitor for some clinical trials
• May participate/present safety material to Investigator’s meetings and other medical meetings
• Participates in selection and bidding activities for vendors and contractors
• Managerial responsibilities as required
• Other duties and ad hoc activities as assigned

EDUCATION AND EXPERIENCE:

• Medical degree (e.g. MD, MBBS)
• At least 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
• At least 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)