About this role
Responsible for the management of the Medical Safety Evaluation Office (MSE) of global products throughout the product lifecycle within the Global Drug Safety and Evaluation Center (GDSEC). Implements relevant policies to ensure the safety of the product in global development and post-marketing portfolio. Accountable for providing medical input to the assessment of the safety profile for each drug and appropriate and timely regulatory reporting of safety issues.
KEY RESPONSIBILITIES
As designated Global Safety Team Chair (GST Chair) for assigned products, is responsible for activities including but not limited to, development of aggregate reports, signal detection process, ad hoc report preparation, and providing recommendations to Global Safety Committee (GSC) on necessary actions to protect patient safety
Provides oversight of medical safety evaluation for assigned global investigational products
Coordinates and contributes to medical assessment for assigned global post-marketing products
Implements and maintains an optimized system for signal detection, risk-benefit management, and safety medical evaluation.
Partner with relevant internal and/or external experts to fulfill responsibilities
Provide medical advice, training, and support to the Pharmacovigilance team and other functions contributing to medical evaluation, signal detection, and risk-benefit assessment activities.
Provides primary liaison between global/local groups and external groups (Drug Safety Monitoring Boards, regulatory agencies, physician communities, and CROs) on product safety related issues as assigned.
Interacts extensively with regional and corporate departments to provide medical/drug safety input to clinical research (scientific and operational), MTDA regulatory affairs, and global quality/manufacturing
Oversees data collection, processing, assessment, and preparation of annual reports, and periodic reports to ensure the timely submission to international regulatory agencies
Responsible for review and finalization of medical assessments of safety data [Periodic/Development Safety Update Reports (PSURs, DSUR), Safety Statements, Safety Surveillance Plans, and Discussion Documents, as appropriate)
Responsible for medical review of medically coded safety data, including adverse events, medical history and concomitant medications
Responsible for review of documents such as periodic safety update reports and benefit-risk evaluation
Responsible for the oversight of safety aspects of the planning, execution, data collection and interpretation of clinical research data
Provides input to senior management, as requested, regarding safety aspects of product development strategy, key messages, data review, and future data needs
Oversees development and preparation of Risk Management Actions Plans for regulatory filings
Supports the development of a Global Pharmacovigilance Team that is fully compliant with all local regulatory requirements
Works with medical affairs team to build awareness of the safety of company products in the medical community, including supporting company sponsored Advisory Boards, participating in medical symposia, publishing, attending media events, and other activities
Accountable for the performance and results of the Medical Safety Evaluation Office within Drug Safety department.
Education:
Medical Degree (MD or DO), and current medical license preferredBoard Certification or equivalent in a medical specialty and significant clinical experience Professional Experience:
Minimum of 10 years pharmaceutical experience in US and international Drug Safety, Medical Affairs, and/or Clinical Development functionsMinimum of 5 years’ management experience leading a drug safety group in the pharmaceutical industryExtensive experience writing pharmaceutical regulatory or clinical research safety documents, including periodic safety reports and risk management plansPost-graduate training in clinical epidemiology and biostatistics is also desirableAbility to travel domestically & internationally as required, typically up to 30%Knowledge and Skills:
Strong interpersonal skills and ability to collaborate effectively with other groups in a matrix organizationThorough knowledge of US and International Safety reporting regulations and guidelines (in particular ICH clinical safety guidelines)Experience in Phase II/III trials, especially with key safety activities Experience in post-marketing/phase IV studies and surveys with key activities (e.g. patient registries, survey protocols)Demonstrated authorship of PSUR, REMS or RMP, and DSURExperience in supervising drug safety personnel, budgeting, organizing and planning for a growing drug safety department supporting multiple products and global expansionExperience with ARISg or other safety database programs
Our Value Proposition:
Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma Development America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits: