PV Data Assurance Lead

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:

The Pharmacovigilance Department is globally united in conducting safety management operations such as collecting, evaluating and reporting safety management information, analyzing accumulated information, and examining and planning safety assurance measures. It is a very rewarding department that contributes to the health of people around the world by collaborating with many overseas members and using our medicines with unwavering trust. We are looking for people who are willing to take on challenges, enjoying their responsibilities and environment, regardless of the past or current situation.

Provides leadership for the Data Assurance team for operational aspects of individual case safety report (ICSR) and literature global standards and drives quality, consistency and operational efficiency across the PV Case Management functions, regions and case processing vendor(s). Reports to the Medical and Data Assurance Lead and is a member of the Medical and Data Assurance Management Team.

Responsible for global ICSR operational quality and consistency within the PV Case Management organization, including work delivered by the case processing vendor(s), which directly impacts the effective management of the safety profile of Astellas development compounds and marketed drugs.

Essential Job Responsibilities:

Implementation and management of the following main operations:

• Maintaining and improving the quality of safety management information

• Examination and strengthening of safety evaluation methods based on regulations

• Participation in process improvement activities and projects related to safety management work

• Operational quality of ICSRs and associated activities

• Operational leadership

• Data Quality Assurance

• Training and mentoring

• People & Organization Management

Organizational Context:

• Reports to the Medical and Data Assurance Lead. Peers include the team Leads in PV Case Management & across PV Operations.

• The Data Assurance Team Lead will manage and lead the team, consisting of 8-12 reports.

• Cooperates closely with the PV Case Management Team Leads and case/literature processing vendor medical staff.

Qualifications:

• Minimum BA/BS (or equivalent) in life sciences

• Minimum of 8 years relevant experience in general case processing within pharmacovigilance or combined PV/RA/QA, and/or clinical development, including extensive leadership experience and ability to lead and manage global, multidisciplinary teams

• In-depth understanding of safety regulations for both marketed and investigational products, and excellent knowledge of global health authority requirements including ICH, CFR 21, FDAAA, EU GVP module, JP regulations,

• Experience in quality and process improvement activities

Skills and competencies:

• Demonstrates effective leadership and management skills, including ability to lead and manage a multidisciplinary team.

• Demonstrates leadership to ensure operational case quality is maintained at the highest standards at all times.

• Strong interpersonal skills and multi-cultural /intercultural awareness; able to negotiate and build consensus for plans and priorities and able to develop effective relationships through collaboration.

• Demonstrated ability to proactively predict and resolve complex problems and/or conflict situations, think strategically and tactically, generate solutions to complex problems and build consensus across the global organization. Able to generate insights and leverage learnings at the individual, team and functional level.

• Ability to perform detailed analysis and integrate analysis results into global standards and policies.

• Advanced problem solving and negotiation skills in complex issues and able to decide independently

• Able to ensure consistency and efficiency as well as monitor and project progress and maintain priorities across regions

• In-depth knowledge of pharmacovigilance processes, data management and adverse event reporting and processing and operations

• Experience with global responsibilities for safety projects

• Able to lead meetings, present orally and interact with external bodies (e.g. Regulatory Authorities)

• Excellent communication and presentation skills in English (written and spoken)

• Additional other languages are an asset

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

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Category Pharmacovigilance

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans