Regional Safety Lead – US & Canada

Position Purpose The primary objective of the Regional Safety Lead is to contribute to the surveillance of the safety profiles of Pfizer products, both under development and marketed, for all therapeutic areas, by ensuring efficient and compliant case intake and reporting operations. This is an above country, regional function. The Regional Safety Lead has organizational and management responsibility for Worldwide Safety (WWS) staff and activities in the Canada and US Drug Safety Units (DSUs) to ensure fulfillment of human safety-related obligations for the Company products, either marketed or investigational, at corporate and local level. Primary Responsibilities Leadership and Strategic Role Accountable for strategic PV activities for the Canada and US DSUs Ensure that the Canada and US DSUs provide input into global and regional strategies to provide optimal support for meeting regional and country business objectives. Responsible for the leadership, development, and performance management of the Canada and US DSU teams to achieve company objectives and culture. Partner with safety functions and non-safety function in regional/global projects to provide expertise and contribution. Direct, mentor, and manage the performance of the Country Safety Team Leads and other direct reports to foster a high-performance culture aligned with corporate values. Maintain expertise in region as well as worldwide regulations and guidelines and promote increased awareness of the legislative and regulatory environment in the countries Champions innovation and compliance Operational Excellence: Execute pharmacovigilance related activities with high-quality and efficiency. Ensure fulfilling of drug safety and medical device related obligations in Canada and the United States in compliance with Pfizer standards and international/local regulations. Support the timely handling of local safety-related regulatory requests with the Country Team Lead. Ensure timely handling of local safety issues; support the Country Team Lead in managing local safety issues in collaboration with central safety functions and local stakeholders. Responsible for identifying and driving process improvement/continuous improvement around areas of direct responsibility. Participate in appropriate committees including WWS leadership team, WWS policy committee, CCIC COQ (Commercial Customer Interaction and Communication Quality Oversight Committee) Responsible for ensuring adverse event reporting case operations teams within the DSUs are following applicable regulations. Facilitate effective communication within the team, with other Safety colleagues and with internal and external stakeholders, to assure that all issues are effectively surfaced for resolution. Ensure fulfilment of human pharmacovigilance and safety-related obligations for the Company products, marketed or investigational. Ensure appropriate communication of safety topics to and from the DSUs. Collaborate with regional and corporate counterparts. Lead in the design, development and implementation of state-of-the-art processes and training for document preparation where necessary. Establish the goals, and manage the day-to-day performance, of the multi-functional team responsible for cross-functional efficient and compliant operations. Support acquisition integrations regionally Monitor and communicate to corporate, regional, national, and DSU level of legislative, regulatory and methodology changes. Communicate policy decisions and develop and monitor implementation plans at DSUs. Monitor the local regulations and guidance, ensure corporate awareness, and proactively address new requirements Partnering with other relevant functions to ensure the continuing upgrade and improvement of safety-related operations at country level, as required by evolving regulations and evolving internal policies and practices. Ensure inspection readiness and inspection success. Ensure subject matter expert (SME) availability and inspection training. Coordinate inspection preparation and conduct. Interact with regulators regarding inspection responses and process expectations. Address inspection and audit findings with root cause analyses, corrective and preventative actions (CAPA) Technical Skill Requirements Knowledgeable in national (US and Canada), international pharmacovigilance regulations and worldwide reporting requirements. Knowledgeable in pharmaceutical business, including drug development and regulatory aspects Good understanding of pharmacovigilance database(s), entry conventions, and workflow requirements Good understanding of medical and scientific terminology Qualifications Advanced degree in medical sciences such as Pharm D, Master’s, PhD Minimum of 5 years management experience, preferably of teams in multiple locations Minimum 10 years' experience in the pharmaceutical industry in pharmacovigilance or clinical research or product development Ability to operate in complex systems and organizations. Ability to manage/oversee in country and ex-country pharmacovigilance partners In depth knowledge of national/regional regulatory legislation and guidelines Highly skilled in time management and change management, organizational and facilitation skills. This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week or more as needed. The annual base salary for this position ranges from $230,900.00 to $384,800.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 25.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. Relocation assistance may be available based on business needs and/or eligibility. Candidates must be authorized to be employed in the U.S. by any employer. U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future. 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. This position requires permanent work authorization in the United States. Pfizer endeavors to make accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email . This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers . Medical