MSI Pharma are working with a small bio pharmaceutical company to seek an experienced Safety Medical Director to join their Neurology team. The main responsibilities for this role is:
* 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
* Provides support and is capable of leading signal detection, signal evaluation, data analysis, and benefit-risk evaluation for assigned compounds, including ability to author signal report in response to Health Authority inquiries
* Provides support and can 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 to predict/establish the safety profile of compounds in clinical development
* Offers medical judgement on complex safety issues
* Works cross functionally with clinical to determine the most appropriate monitoring and stopping rules for clinical trial protocols in partnership with the project's medical monitor
* Supports and can present 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 * 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 clinical studies
* 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 operates (i.e., through review of scientific journals, attendance at scientific and key technical meetings, etc.)
* May support and/or contribute to writing of white papers and other internal scientific publications
* Assist in accomplishing department and corporate objectives
* 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
