Medical Quality Issue & Product Management Lead
Medical Quality Issue & Product Management Lead
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$ 219800 - 366400
1 Vacancy
Job Description
The Global Medical Quality Governance (GMQG) Medical Quality Issue & Product Management Lead within Medical Enablement & Quality (MEQ) is accountable for ensuring that Medical provides the mandatory leadership for the Maintenance and Defense (M&D) of the entire product portfolio worldwide.
The lead will be responsible for Rapid Response teams & Health Hazard Assessments relating to Pfizer products ensuring a fair & wellinformed balance in its assessment of decisions for product withdrawals in accordance with REG21 and Medical Executive Committee policies.
The lead will provide the medical and scientific expertise essential to take informed decisions that may have a significant impact at the enterprise level (financial and reputational) such as the BenefitRisk assessment of products or recommendation for products recalls of the portfolio.
Accountable for overseeing the leadership of the GMQG centralized Medical Quality Issue management team that conducts quality event investigations for medical quality events in compliance with QMS01 requirements. Responsible for partnering with GMQG reporting colleagues to track quality event performance with metrics for stakeholders and MQOC/PVR QOC as appropriate.
The position will have the following responsibilities:
- Lead the Global Medical Product Evaluation team (GMPE) primarily responsible for the medical/medical affairs activities relating to benefit/risk; rapid response teams and health hazard assessments relating to Pfizer products. Work closely with senior leadership in Safety and Regulatory and represent medical in key decision making relating to the benefit risk of Pfizer products.
- Ensure that goals are met and the portfolio is supported with the appropriate medical framework to ensure business success and compliance. Oversight responsibility and medical point of contact for all (M&D) related issues across the portfolio of products.
- Responsible for enforcing appropriate processes regarding M&D liaising with Regulatory Safety and other functional lines as well as with Medical Affairs & Clinical Development.
- Provide medical leadership in the management of safety issues and safety letters
- Provide a critical review & medical input into communications materials when warranted
- Lead a team based in a lowcost offshore location responsible for conducting selected core medical quality activities related to Maintenance and Defense and other relevant quality activities to be determined. Responsible for setting KPIs and monitoring the progress of the team.
- Lead development of tools and processes that ensure smooth efficient and compliant operations of the offshore team
- Lead issue management activities for medical quality events in compliance with QMS01
Qualifications
- MD PharmD or advanced scientific degree is required
- 13 relevant experience in Global Clinical and Medical affairs Pharma QMS Development and Management Regulatory Affairs Clinical Quality GCP audit readiness Regulatory Inspections experience is preferred
- Demonstrated indepth knowledge of relevant processes compliance regulatory requirements and other global/local evolving legislation
- Strong GxP Quality Management System development & oversight experience
- Familiarity with pharmaceutical product development
- Experience with medical and/or technical review of submissions to regulatory authorities (EMA/FDA) is highly desirable
- Demonstrated ability to effectively navigate ambiguity (high learning agility) develop a path forward and successfully execute to drive results
- International travel as required in support of GMQG leadership collaboration and/or the offshore responsibilities associated with this role
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers develop and coach others oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Work Location Assignment:Hybrid
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care providers name address and the type of payments or other value received generally for public disclosure. Subject to further legal review and statutory or regulatory clarification which Pfizer intends to pursue reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse your name address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race color religion sex sexual orientation age gender identity or gender expression national origin disability or veteran status. Pfizer also complies with all applicable national state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an EVerify employer. This position requires permanent work authorization in the United States.
Employment Type
Full-Time
