Astellas Pharma Director Aggregate Safety Assessment in Northbrook, Illinois
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 & Scope:
The Director, Aggregate Safety Assessment will provide scientific leadership, execution, and oversight of worldwide ASA activities and contribute to the development and maintenance of excellence in Aggregate Safety Assessment.
Essential Job Responsibilities:
Contributes to the implementation of the GPV 3-5 year strategic plan with a focus on short- and long-term enhancement of Aggregate Safety Assessment, Safety Science and the global PV system.
Responsible for effective and regular communication between GPV partners including EU QPPV and Japan Safety Control Officer in order to ensure GSS objectives are achieved in line with overall GPV business objectives.
Interfaces cross-functionally with Regulatory Affairs, Quality Assurance, Medical Sciences, Medical Affairs, local affiliates, Clinical Data Science, Clinical Pharmacology and Exploratory Development, Legal, Project Management and counterparts in the all regions.
Lead the ASA contribution to the management of safety signals for Astellas developmental and marketed products.
Provide advice as a pharmacovigilance specialist in the creation and maintenance of the Safety Signal Surveillance Strategy, the collection of safety data for signal surveillance activities including the use of the global Astellas Safety Signal and Evaluation Tool (ASSET).
Responsible for high quality contribution to periodic safety reports (e.g. PSURs, DSURs) and ad hoc (e.g. benefit-risk assessment documents in response to Health Authority requests). This extends to supporting regulatory strategy and preparation of safety-related data for submission to Health Authorities.
Supports GPV in contributing ASA expertise during PV inspection/audits including the EU-QPPV office and the JP-Safety Control Officer.
Timely execution and submission of responses to inspection findings associated with ASA and for planning, creation, submission, implementation, maintenance and follow-up of corrective and preventive action plans related to ASA, ensuring feasibility and global alignment where possible in collaboration with the other functions within GPV.
Responsible for the identification, development, implementation and communication of process improvements tools, systems and procedures within GPV to assure optimal efficiency and consistency in aggregate safety assessment.
Participates in global and regional teams contributing to e.g. cross-functional process improvement projects and global initiatives.
Provide leadership of the ASA team comprising of approximately 6-8 direct reports.
Accountable for recruitment, supervision and development of direct reports, setting and monitoring objectives, performance management, resource planning, allocation and budgeting.
This position reports directly into the Senior Director of ASA and is may have 6-8 direct reports.
A postgraduate Science or Medical degree ( PhD, MS, Pharm.D, MD). Additional degree in public health concentration is desirable (e.g. MPH, Epidemiology, etc.).
At least 5-10 years pharmaceutical/health related industry experience with 4 years pharmacovigilance experience, including advanced pharmacovigilance functions through development and post-authorization required.
Team leadership experience, managing academic level professionals (e.g. scientists/PhDs) preferred.
Significant and demonstrable working knowledge of pharmacovigilance regulations and guidelines, including FDA, ICH, EU, and PMDA regulations.
Able to work effectively and influence across cultures and functions.
Astute observational and analytical skills with a sense of urgency
Maintain composure in stressful/adverse situations
Able to contribute to strategic decision-making and high-level thinking and make complex scientifically based assessments and interpret/apply scientific data.
Global experience in Aggregate Safety Assessments preferred.
Medical, Dental and Vision insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays, including year-end shutdown
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
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans