Astellas Pharma Associate Medical Safety Director (Oncology/Ophthalmology) in Northbrook, Illinois
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing an Associate Medical Safety Director opportunity in Northbrook, IL.
Position & Scope:
Reports to the Group Lead of the Global Therapeutic Area (TA) or the Medical Director/ Director, is a member of the Global Therapeutic Area and assists in ensuring the effective translation and execution of the Global TA operating plan such that Global TA, Medical Safety (MS), and Pharmacovigilance (PV) strategic goals are achieved.
Responsible for providing medical safety leadership and direction to Global TA colleagues and support to the Global TA Group Lead with regards to the design and successful implementation of medical safety strategies for drug products within the Global TA, by authoring, reviewing and, as appropriate, approving medical-scientific reports, safety analyses and evaluations and ensuring cross-functional implementation and follow-up with the appropriate stakeholders in and outside MS and the PV organization.
For specific Astellas products assigned to the Global TA, accountable as a product responsible person (PRP) for proactive safety surveillance of Astellas drug products, both those in development and marketed products, including leading PV Product Responsible Teams as a pharmacovigilance specialist, ensuring the medical safety for the assigned compounds or products, contributing to an optimal benefit/risk profile and responsible for the design and successful implementation of signal management and risk management strategies for assigned products in the Global TA.
Essential Job Responsibilities:
Medical Safety Activities Product Responsible person (PRP):
Responsible and accountable for the coordination and medical-scientific monitoring and assessment of the safety profile of one or more specific Astellas products assigned to the Global TA.
As this position is expected to function autonomously, without a great deal of oversight from the Group Lead or (Medical) Director, assigned products may be those requiring more specialized expertise, such as products in development, in particular high priority/ fast-tracked Global Development projects and those requiring specialized knowledge within a therapeutic area, indication, or drug class; products with multiple license partners; products being developed in or marketed in multiple regions; high priority marketed products.
Leads PV Product Responsible Teams for assigned products, co-chairs Global Development Safety Management Teams, and participates in Global Development Core Teams and Global Medical Affairs Core Medical Teams as the pharmacovigilance specialist, ensuring the medical safety of products for the assigned Global TA and contributing to an optimal benefit-risk profile.
Responsible and accountable for the timely identification and communication of emerging safety issues and safety updates of the Company Core Data Sheet, Investigator's Brochure and local product labeling. This also includes responsibility for effective and regular communication with the Global TA Group Lead and with the applicable QPPV.
Responsible and accountable for the design of safety surveillance strategies, management of safety signals for Astellas drug products, both those in development and marketed products, for the collection and identification of safety signals using safety data for signal surveillance activities, categorization and prioritization of safety signals and for authoring, medical review and, as appropriate, approval of safety evaluation reports (SERs), working closely with Safety Science.
Responsible and accountable for the risk management of assigned Astellas drug products, both those in development and marketed products, the development and submission of the Risk Management Plan (RMP) and for the execution of risk management strategies in collaboration with internal and external stakeholders, working closely with Safety Science.
Responsible and accountable for timely and high-quality contribution to periodic and ad hoc (e.g. Health authority requests) safety reports for assigned products in terms of authoring and review of medical sections, the overall medical-scientific analyses and conclusions.
Responsible and accountable for the ongoing monitoring and assessment of the safety profile of assigned Astellas developmental and marketed products as a member of study teams and for representing PV in the design, conduct, analysis and reporting of Phase 1 -- Phase 3 clinical trials and Post-Authorization Studies.
Strategy Development and Execution
Supports the Global TA Group Lead, and, as appropriate (Medical) Director in the identification, development, implementation and communication of process improvements tools, systems and procedures within GMS to ensure efficiency and consistency in safety surveillance in the assigned Global TA and other Global TAs and Regional Teams within MS, as well as on PV level.
Supports the Global TA Group Lead, and, as appropriate (Medical) Director in inspection/audit preparation, timely execution and submission of responses to findings and for timely planning, creation, submission, implementation, maintenance and follow-up of corrective and preventive action plans related to the respective Global TA, ensuring feasibility and global alignment in collaboration with the MS Leadership team.
Responsible and accountable for adequate benefit-risk assessments for assigned Astellas drug products within the Global TA. Inadequate benefit-risk assessments may have negative impact on product success, such as delays in regulatory authority approvals and imposition of restrictive labeling, and direct and consequential threat to the viability of drug applications for regulatory approval owing to medical safety strategy quality and standards weaknesses
- Reports to the Group Lead, Global Therapeutic Area, Senior (Medical) Director, Medical Safety or the (Medical) Director, Global Therapeutic Area.
- Peers in this position include fellow Associate (Medical) Directors in other Global TAs within MS.
- Collaborates with the Global TA Group Lead and (Medical) Director; individuals in their analogous functions within MS, PV (in particular PV Process and Safety Science), Global Development, and Medical Affairs.
- Bachelor's degree required; advanced professional degree in scientific, health-related field (e.g. PharmD or PhD) strongly preferred (pharmaceutical industry experience in a relevant therapeutic area preferred); or M.D. or D.O. strongly preferred (board certification in medical specialty or pharmaceutical industry experience in a therapeutic area preferred).
- For Associate Medical Director title: Holds an appropriate medical degree
- For Associate Director title: Does not have a medical degree but meets other requirements.
- Minimum of at least 6 years of experience with M.D., D.O., PhD, or PharmD degree, and at least 8 years of experience with bachelor's or master's degree, in the pharmaceutical industry and/or a relevant health science setting (such as academia). Direct exposure to pharmacovigilance functions, additional regulatory and/or clinical development experience is a plus.
- In-depth understanding of safety regulations for both marketed and investigational products, and excellent knowledge of regional and global authority requirements, including ICH, and other applicable requirements, able to influence decisions relating to patient safety and assessment of benefit-risk.
- Experience in planning, allocating and managing multiple projects.
- Demonstrated leadership capabilities, including the ability to work within a matrix environment and lead multifunctional teams.
- Sound medical scientific knowledge to evaluate and interpret clinical and scientific data and to communicate with both internal and external stakeholders.
- Specific working knowledge and experience in medical safety functions, including risk, signal management and periodic reports.
- Excellent communication and presentation skills in English (both written and spoken).
- Strong interpersonal skills required with a demonstrated ability to handle conflict situations, think strategically, generate solutions to problems, build consensus across the Global TA and MS, and understand differences in both regulations and cultures.
- Ability to deliver under pressure with limited resources.
- Ability to travel to meet the needs of the role.
- Can be located in Northbrook, US, Leiden, Netherlands, or Tokyo, JP.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled