Safety Surveillance & Risk Management Disease Area Cluster Lead, MD
Job Description
As an experienced medical safety professional, the role requires one to exercise the highest quality of medical judgment to inform a robust understanding of the benefit-risk profile across Pfizer’s portfolio and to advocate for patient safety from first-in-human and throughout a product’s lifecycle. The Safety Surveillance & Risk Management (SSRM) Disease Area Cluster Lead is accountable for the global medical safety management of Pfizer products in his/her disease area. The SSRM DACL seeks innovative ways to continually improve our approach to signal detection, evaluation and management to ensure Pfizer products are safe for patients.He/she will provide organizational leadership within SSRM and within Pfizer, including:
- Managing one or more SSRM Disease Areas, including supervision of the Safety Risk Leads (SRLs) globally supporting the respective Disease Area(s)
- Overseeing and performing proactive safety surveillance and risk management to effect product safety signal detection & evaluation, risk assessment and safety risk minimization
- Working with other Pfizer functions engaged in benefit-risk management (Regulatory Affairs, Quality, CMO, Corporate Audit, etc) to enable one medical voice
- Articulating clear and informed medical judgement to enable sound business decisions and to enable productive engagement with health authorities
- Developing talent and leadership across SSRM
Responsibilities
Primary Responsibilities
The Disease Areas Cluster Lead:
- Is an integral participating member of the SSRM-LT. They may represent SSRM Unit Head in WWS management and operational matters, and may be a member of the Extended PVLT
- Effectively communicates resource, timeline and other Disease Area and product issues as appropriate to the SSRM Unit Head
- Supports the role of the SRLs, acting as both a manager and individual contributor performing senior SRL responsibilities when needed which includes performing proactive safety surveillance and risk management/minimization of Pfizer’s portfolio of products
- Conducts proactive resource planning and manages flexible and dedicated resources across their Disease Area(s) to ensure appropriate surveillance of Pfizer’s portfolio of products
- Is responsible for the effective leadership of an engaged team of colleagues performing in an appropriate work environment, and for the related training and development, performance management, succession planning, and human resources processes, all while ensuring compliance with required regulations and practices
- Develops a culture of courage, excellence, equity and joy within the team including regular communications, coaching, and mentoring of the team as required
- Directly contributes to Safety Strategy activities, especially those defined by SOPs
- Supports the SRLs with their responsibility of acting as a Safety point of contact to the Asset Teams and Chairs of the Risk Management Committees (RMCs), ensuring a unified communication on safety matters for WWS
- Reviews and approves critical safety documents regarding the B-R Profile of Pfizer’s products
- Represents Pfizer WWS at senior internal (e.g. governance and BU Disease Area Leadership teams) and external forums (e.g. FDA interactions)
- Leverages focused expertise across BU segments and deployment to support due diligence in-licensing assessments
- Identifies opportunities for consistency and standards for safety surveillance and risk management processes
- Innovates, champions and implements novel approaches to safety surveillance and risk management across disease areas, including engagement in continuous improvement initiatives
- Provides active inspection readiness support, including provision of data for metrics and activity tr
Job Requirements
Qualifications
- Medical degree and 5+ years of experience (e.g. patient care, clinical trial experience/investigator, academic medicine, specialty training and/or board certification), and/ or scientific, and/or pharmacovigilance or and/or drug development
Additional Qualifications
- Managerial/supervisory experience
- Disease area-specific knowledge
- Relevant knowledge of pharmaceutical company organizational structure, policies, and practices, as applicable to safety risk management
- Thorough understanding of safety risk management internal and external environment, including applicable regulations and guidances.
- Comprehensive knowledge of drug development process and post-marketing experience, including and understanding of safety context across the drug lifecycle
- Ability to influence internal and external stakeholders
- Ability to act independently, seeking guidance as appropriate; recognizes other colleagues’ areas of expertise and engages them effectively to achieve team objectives.
Technical Skills Requirements
- Ability to lead a team of medical professionals and lead through example, commitment and enthusiasm in a matrixed environment
- Strong scientific and medical knowledge, including fluency in the medical literature
- Ability to integrate data to support benefit/risk decision-making
- Understanding of statistics and analytical tools
- Knowledge of global safety/regulatory issues and concerns as they relate to the business or clinical research-based compound development
- Proactive resource management
- Effective verbal and written communication skills.
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 - requirement is 3 days onsite per weekThe annual base salary for this position ranges from $256,100.00 to $426,800.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 30.0% 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 | (uscandidates.mypfizerbenefits.com). 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.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.Medical
