Sr. Director, Aggregate Safety Assessment

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

1. 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.

2. Develops and leads the successful implementation of annual Aggregate Safety Assessment strategic goals and objectives.

Technical Content:

The ASA Lead will be accountable for:

1. 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

1. 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/medico[1]scientific 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

1. 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.

1. 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.

Quantitative Dimensions:

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

Successful transition

• 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.

Organizational Context:

• 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.

Qualifications:

Required

• 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

Benefits:

• 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

#LI-SS

Category Pharmacovigilance

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