Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
Purpose and Scope:
Reports to the Group Lead of the Global Therapeutic Area (TA), is a member of the Global Therapeutic Area and participates in the creation and execution of the Global TA strategic plan and ensures 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 assigned Global TA members 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 Global TA project 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.
Leads Global TA project 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 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
Assists in the identification, development, implementation and communication of process improvements tools, systems and procedures within MS to assure 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.
Participates and supports the Global TA Group Lead 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.
People & Organization Management
Manages a specific group of physicians and scientists within the assigned Global TA through successful recruitment, supervision and development of direct reports, setting and monitoring objectives, performance management, resource planning and allocation and budgeting in close collaboration with the Global TA Group Lead.
Ensures an appropriate level of safety training for team members and ensures goals are achieved and appropriate growth in technical skills, team membership/communication skills and other identified areas for improvement are achieved.
Displays the highest level of personal commitment to the Astellas code of Ethics. Inspires team members while holding accountable. Commits through co-accountability, to the growth and health of the Global TA, MS and PV as a whole.
Responsible and accountable for adequate benefit-risk assessments for assigned Astellas drug products within the Global TA. Inadequate risk-benefit 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.
May have approximately 2-4 direct reports (physicians and scientists, which may include consultants/ contractors as well as permanent employees) with responsibility for one or more products within the assigned Global TA; team members can be located in different regions.
Peers in this position include fellow (Medical) Directors in other Global TAs within MS.
Collaborates with the Global TA Group Lead; individuals in their analogous functions within MS, PV (in particular PV Process and Global Safety Science), Global Development, and Medical Affairs.
M.D. or D.O. (board certification in medical specialty or pharmaceutical industry experience in a therapeutic area preferred)
Prior experience with Ophthalmology and pharmacovigilance
Minimum of at least 7 years of experience 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 responsibilities, mentoring and people management abilities.
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.
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Referral bonus program
Category Medical Safety Science
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans