Sr. Director, Medical Devices Center of Excellence Head (Worldwide Safety)
: $186,460.00 - $186,460.00 /year *
: Healthcare - Allied Health
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Pfizer is excited to present a Senior Director, Medical Devices Center of Excellence (DCoE) Head position. This is a senior leadership position within Pfizer's Worldwide Safety (WWS) organization, responsible for providing leadership and innovation into medical devices' and combination product clinical and post market surveillance safety monitoring (device vigilance) and post market clinical follow-up with a focus on defining and ensuring implementation of best practices for devices' clinical/medical safety and benefit risk assessment management planning as well as ensuring Pfizer's compliance with devices' global safety/vigilance regulations.
In a highly visible role, the WWS DCoE Head develops organizational policies and standards in compliance with regulatory requirements and oversees a team of Devices-SMEs. They will be a key interface with Safety and PGS Manufacturing SMEs to ensure alignment/agreement on devices policy and on product technical topics. They will also chair Pfizer device safety senior forums and interface on behalf of Pfizer with global Health Authorities.
Drives the execution of strategic and pharmacovigilance process-related activities required to support the development and maintenance of the clinical development and post marketing safety of Devices and Drug-Device Combinations within the Pfizer portfolio (e.g. for sterile injectables drug-device combination products, devices in development and post-approval).
Liaises with Safety Risk Leads (SRL) who have expertise in the safety and risk management for the development and post-market surveillance of medical devices and the device component of drug/biologic-device combination products, all standalone devices in Development and in marketed standalone devices; all Drug Delivery Devices in development projects and all marketed device-only standalone products (Software Medical Devices and others).
Support Design History File (DHF) projects.
May, upon request from WWS leadership, take on certain drug/biologic-device combination projects in development or marketed, where the device component is complex or very significant from a patient safety, regulatory, quality, or manufacturing perspective.
Chairs pan-WWS Devices Governance Committees, such as Device Steering Committee
Represents WWS on the pan-PFE Devices governance and process meetings
Responsible for Device Inspection and Audit readiness
Ensures clinical/medical safety compliance with all global device regulations.
Interfaces with Pharmacovigilance Policy Committee and quality oversight committees as appropriate
Interfaces with Pharmacovigilance Operations group as appropriate.
Interfaces with PGS Manufacturing to ensure alignment and agreement on Devices Policy and on Product Technical Topics.
Develops and enhances Device clinical-safety related procedures. Ensures alignment and consistency in the development and execution of device safety/monitoring related procedures at Pfizer. Accountable for establishing the policies/standards of performance of the Safety work in scope including input into risk analyses, risk evaluation, risk mitigation plans and activities, risk control plans and risk files owned by the manufacturing sites.
Responsible for effective and timely implementation of pharmacovigilance best practices.
Assures use of best practices in Devices benefit-risk assessments.
Assures post market clinical follow up data collection and feedback into safety aspects of device clinical evaluation.
Provides strategic and process guidance to the Safety Risk Leads and other roles supporting Devices in WW Safety
Supports the conduct of device products' Risk Management Committees/Safety Management Teams.
Serves as the key interface between the WWS DCoE and the BUs' device communities related to Devices safety.
Innovates in Devices safety sciences.
Maintains a high-level view of all devices projects that the organization is undertaking or considering undertaking.
Monitors/understands changes in the regulatory area, defines implications for Pfizer and converts to actionable program activities.
Utilizes knowledge of integrated body systems' pathophysiology to evaluate the impact of device/drug-device issues (e.g. malfunction)
Assesses the suitability of Devices and Drug-Device Combinations based on typical physician practice within various health systems, hospital and non-hospital patient care facilities
Ensures Devices and Drug-Device Combinations fulfill quality medical care
Bachelor's of Science required
15+ years of broad and progressive medical devices experience in medical, clinical or pharmacovigilance but with a clear focus on devices clinical safety monitoring and Benefit Risk management.
Advanced leadership and managerial experience overseeing technical medical/scientific senior staff.
Medical Devices industry experience in safety signal monitoring and detection, safety signal evaluation and Benefit-Risk assessment and management.
Device specific development experience and marketed devices experience, and in particular thorough knowledge of the devices safety regulatory requirements globally (e.g. experience of interacting with EU Notified bodies and other Regulatory agencies, etc.).
Thorough understanding of Medical Devices Safety Risk Management internal and external environment, including applicable regulations and guidances, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, and ISO 9001.
Comprehensive knowledge of medical devices development and post market clinical follow up processes.
Experience with DfSS/DMAIC Green Belt / Black Belt
Can handle more than one complex project simultaneously, prioritizing well and recognizing key issues.
Ability in, and track record of, working effectively in an advanced matrix structure, including matrix team leadership/representation preferred.
Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
Biomedical Engineering background with strong Pharmaceutical Devices/Drug-Device Combination clinical/medical safety and regulatory experience; knowledge and understanding and knowledge of principles, theories, and concepts relevant to Device Engineering (e.g., CQE body of knowledge)
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 provider's 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 E-Verify employer.
Other Job Details:
Last Date to Apply for Job: September 10, 2019
Additional Location Information: New York, NY; Peapack, NJ; Collegeville, PA; Groton, CT.
Eligible for Relocation Package
Eligible for Employee Referral Bonus
#LI-PFE N (Other) (United States of America) Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.