Job Description
Company Description
Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies.
Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy.
Responsible for the management of the Medical Safety Evaluation Office (MSE) and lead all medical aspects of safety assessments and safety management of assigned global products throughout the product lifecycle (development and marketed). Will lead and chair global safety teams in the assessment of safety data, signal management, risk management collaborating with international affiliates and MTPC corporate. Will lead projects and process improvement to support the global safety function within GDSEC and MTPG.
Job Description
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.
Qualifications
Education:
• Medical Degree (MD or DO), and current medical license preferred
• Board 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 functions
• Minimum of 5 years' management experience leading a drug safety group in the pharmaceutical industry
• Extensive experience writing pharmaceutical regulatory or clinical research safety documents, including periodic safety reports and risk management plans
• Post-graduate training in clinical epidemiology and biostatistics is also desirable
• Ability 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 organization
• Thorough 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 DSUR
• Experience in supervising drug safety personnel, budgeting, organizing and planning for a growing drug safety department supporting multiple products and global expansion
• Experience with ARISg or other safety database programs
Additional Information
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:
Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies.
Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy.
Responsible for the management of the Medical Safety Evaluation Office (MSE) and lead all medical aspects of safety assessments and safety management of assigned global products throughout the product lifecycle (development and marketed). Will lead and chair global safety teams in the assessment of safety data, signal management, risk management collaborating with international affiliates and MTPC corporate. Will lead projects and process improvement to support the global safety function within GDSEC and MTPG.
Job Description
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.
Qualifications
Education:
• Medical Degree (MD or DO), and current medical license preferred
• Board 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 functions
• Minimum of 5 years' management experience leading a drug safety group in the pharmaceutical industry
• Extensive experience writing pharmaceutical regulatory or clinical research safety documents, including periodic safety reports and risk management plans
• Post-graduate training in clinical epidemiology and biostatistics is also desirable
• Ability 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 organization
• Thorough 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 DSUR
• Experience in supervising drug safety personnel, budgeting, organizing and planning for a growing drug safety department supporting multiple products and global expansion
• Experience with ARISg or other safety database programs
Additional Information
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:
💡 Quick Summary
Seeking a career-building opportunity? The Senior Medical Director - Medical Safety Evaluation position is now open for candidates interested in the Lab Technician / Pharmacist Jobs sector. This role in Los Alamos offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Lab Technician / Pharmacist Jobs is a plus.
