Associate Director Medical Safety

About Astellas

At Astellas we are a progressive health partner, delivering value and outcomes where needed.

We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.

We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.

Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.

We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.

Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.

About This Job

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 Therapeutic Area operating plan such that Global Therapeutic Area, Medical Safety (MS), and Pharmacovigilance (PV) strategic goals are achieved.

Responsible for providing medical safety leadership and direction to Global Therapeutic Area colleagues and support to the Global Therapeutic Area Group Lead about the design and successful implementation of medical safety strategies for drug products within the Global Therapeutic Area 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 Medical Safety and the Pharmacovigilance organization.

For specific Astellas products assigned to the Global Therapeutic Area, accountable as a product responsible person (PRP) for proactive safety surveillance of Astellas drug products, both those in development and marketed products, including leading Pharmacovigilance 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 Therapeutic Area.

Essential Knowledge & Experience:

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 Leads Pharmacovigilance Product Responsible Teams for assigned products, co-chairs Global Development Safety Management Teams, and marketed in multiple regions; high priority marketed products.
• Leads Pharmacovigilance 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-Authorisation Studies. of Phase 1 – Phase 3 clinical trials and Post-Authorisation Studies.

Preferred Knowledge & Experience:

• 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 MD or DO 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.
• Extensive experience with MD, DO, PhD, or PharmD degree, and significant experience with a 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, and 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.

 Additional information

• Type of role permanent.
• Location: Netherlands, US, Japan.
• Hybrid work.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.