Astellas Pharma Sr. 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, Leiden, The Netherlands, the UK or Tokyo, Japan. 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:
Responsible for development and maintenance of excellence in Aggregate Safety Assessment.
Reports to the Executive Director, Medical Safety Analyses and contributes to the development and implementation successful execution of the GPV mission, objectives and 3--5-year strategic plan.
The Aggregate Safety Assessments group (ASA) is responsible for:
Lead and oversee the periodic aggregate safety reporting activities in Global Pharmacovigilance (GPV) to enhance quality of Astellas pharmacovigilance activities and to ensure excellence in periodic aggregate safety reports mandated by worldwide regulatory authorities
Establish the best practice of periodic aggregate safety reporting activities as well as ad-hoc reporting to ensure the safety of Astellas' products
Ensure that GPV staff is fully and appropriately informed of, and trained on, global regulatory requirements and guidelines for periodic reporting
Establish and maintain closely alliances with relevant functions --both internal (GPV) and external (RA, GMA, Clinical Development) partners -- to ensure high-quality periodic reporting activities
Strictly comply with all relevant authorities / regulations
Leads, executes and oversees the worldwide ASA activities: both in-house and outsourced ASA activities
Essential Job Responsibilities:
Strategy Development and Execution
Contribute to development and implementation of 1-3-year Medical Safety Science and Aggregate Safety Assessment specific objectives and plans as part of the overall GPV strategy and plans. Participates with the Executive Director, Medical Safety Analyses and as a member of the GPV Extended Management Team in the successful execution of GPV vision, mission, objectives and plans.
Develops and leads the successful implementation of annual Aggregate Safety Assessment strategic goals and objectives.
The ASA Lead will be accountable for:
- Global ASA Strategies
Develop and execute the budget for global ASA management
Develop and implement ASA strategy across the entire Astellas organization
Working closely with the Signal Management and Risk Management Leads, provide critical support to all the TA Heads
Managing outsourced vendors for periodic/ medical writing
Report scheduling and tracking of Aggregate Periodic Reports
Closely liaise with Regulatory Affairs
- Operations of ASA
Establish high quality standards to periodic (e.g. PBRERs, DSURs) and ad hoc (e.g. benefit-risk assessment documents in response to Regulatory Authority requests) safety reports and other reports authored by other departments (e.g. study protocols, clinical study reports, Investigator's Brochure, product label), in terms of leading the authors of the safety/medicoscientific sections and contributing to overall analyses and conclusions.
Provide expert guidance and close support to all TA heads and leads, and establish and monitor operations of PBRER, PADER/PAER, DSUR, ACO and IPSR and others as appropriate
Accountable for compliance with regulatory standards and timely delivery of all global and regional periodic documents of high quality in collaboration with RA and Global PV
Build and maintain close cross-departmental and cross-divisional relationships with all function heads in global pharmacovigilance, including EU-QPPV and JP-QPPV, RA, GMA and Clinical Development
Supports regulatory strategy and preparation of safety-related data for submission to Health Authorities
Ensure quality, accuracy, timeliness and efficiency of ASA activities and results
- Collaborating with other members of Medical Safety Science
Support the functioning of the TA Leads
Establish relationship with, and support of, other functions within Medical Safety Science
Build and maintain close relationships with all functions within GPV, as well as responsible for cross-departmental interactions with relevant functions
Together with the TA Head and Leads, share accountability for responses to both global and regional authorities.
- Quality Management
Supports PV inspection/audit issues as an ASA expert contributing to non-PV inspections/audits (e.g. GCP) as necessary and supporting the QPPV office in corrective and preventive action plans related to medical safety.
Maintains up-to-date knowledge on regulations related to ASA Management and advises the Executive Director, Medical Safety Analyses on the impact of any new or revised ASA regulations
Contributes towards the development of the pharmacovigilance ASA training curriculum and is responsible for the correct (medico-scientific) content of training materials.
Represents Global PV in large (cross-) functional ASA training sessions promoting pharmacovigilance awareness and providing ASA specialist education across internal and external audiences.
Advises the Executive Director, Medical Safety Analyses in optimizing cross-functional process improvement initiatives within the field of ASA, to produce or strengthen consistent and standardized ASA processes across the organization.
People & Organization Management
Responsible for the effective implementation of optimal organizational structure(s) which maximizes on the use of resources globally and reflects business needs and conditions.
Develops an environment to enable each member of Aggregate Safety Assessment to optimally operate in the matrix environment of GPV and Astellas.
Manages the Aggregate Safety Assessment function and its people, through successful recruitment, performance management, development planning and retention of a high performing team.
Effectively delegates responsibilities to achieve ASA goals and effectively develops and aligns individuals to the best of their abilities, while ensuring optimal oversight and supervision to ensure goals are achieved and appropriate growth in technical, leadership and team membership skills.
Compliance with global regulation
Manage and oversee PBRER, PADER/PAER, DSUR, ACO and IPSR and other local report type activities without deficiency
Timely tracking and with QMS monitor compliance as part of project management
Establish best practice consistent with global regulatory guidelines and requirements and ensure staff is appropriately trained
Ensure global consistency among all periodic reports, (D) RMP and other regulatory documents which contain safety information as well as ICSRs as appropriate
Improve quality, efficiency, and adequacy of reporting activities
Achievement of the financial target
- Manage and achieve budget of ASA
Define, install and implement the global ASA function using a staged approach such that ongoing and future Astellas business needs are ensured and continuous progress is evident.
Manages the oversight of an average of 150+ periodic safety reports on an annual basis as well as other line listings and respones to assessment reports.
Reports to the Executive Director, Medical Safety Analyses and peers include the Leads in Epidemiology/Signals, Risk Management and Therapeutic Area Leads, as well as the corresponding Heads/Leads in relevant divisions across Astellas. The ASA Lead may have 3-10 direct reports who are co-located in the US, EU, and Japan.
Collaborates with the Therapeutic Area, Signal Management and Risk Management/Epidemiology Head and Leads
Collaborates with his/her peers in EU-QPPV and JP-QPPV, RA, GMA, Clinical Development and Pharmacology.
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 10 years of experience in the health science-related industry with direct exposure to clinical, regulatory or pharmacovigilance functions, including;
5 years pharmacovigilance experience (advanced pharmacovigilance functions from development and post-authorization)
Management or team experience, managing academic level professionals (e.g. physicians, scientists).
Direct management experience.
Significant and demonstrable working knowledge of global pharmacovigilance regulations and guidelines, including US, ICH and EU regulations.
Skills and Competencies
Demonstrates effective leadership and management skills, including ability to lead and manage a multidisciplinary team of physicians and scientists (including line managers)
In-depth knowledge of pharmaceutical medicine, including pharmacovigilance knowledge of therapeutic areas in which Astellas operates
Experience with global responsibilities for products/safety projects
Excellent communications skills with fluent English (spoken and written)
Able to lead meetings, present orally and interact with external bodies
Able to work effectively and influence across cultures and functions
Proven problem-solving skills and able to work independently
Able to manage multiple projects simultaneously and has excellent time management skills
Astute observational and analytical skills with a sense of urgency
Accuracy and attention to detail
Creative and innovative thinking
Able to maintain composure in stressful/adverse situations
Able to contribute to strategic decision-making and high-level thinking
Able to make complex medically/scientifically based assessments and interpret/apply scientific data
Results oriented and ability to deliver high-level quality documents
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
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