Director, Safety Risk Lead

Position Purpose

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) Safety Risk Lead is accountable for the global medical safety management of Pfizer products and performs proactive signal detection and evaluation, and risk assessment/minimization to ensure Pfizer products are safe for patients. 

This leader will provide organizational leadership within SSRM and Pfizer, including:

• 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, Quality, Clinical, Medical, 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.

Primary Responsibilities

• Acts as a Safety point of contact for the Asset Teams and chairs the Risk Management Committees (RMCs), ensuring a unified communication on safety matters for Worldwide Safety (WWS)
• Chairs RMCs and Core Working Groups for his/her assigned products with minimal oversight
• Represents Pfizer WWS at internal (e.g. governance and business unit disease area leadership teams) and external forums (e.g. regulatory authority and business partner interactions) as appropriate
• Evaluates safety data of any source with minimal oversight, identifies and analyzes safety signals, and presents medical evaluation of safety signals and benefit-risk assessments to the appropriate forums
• Provides disease-area specific pharmacovigilance expertise and applies this to various business unit products that are assigned
• Prepares action plans independently to address risk and benefit-risk issues, often requiring cross-functional activity to address safety issues and risk minimization plans
• Reviews and approves safety documents including those pertaining to the B-R profile of Pfizer's products
• Ensures consistency of safety risk messaging for a particular product or class of products, across multiple indications/BUs. Represents SSRM on due diligence activities; coaches others in due diligences to support Pfizer's business plan
• Represents SSRM on due diligence activities; coaches others in due diligences to support Pfizer's business plan
• 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 Pfizer's portfolio of products: engages in continuous improvement initiatives, Safety Sciences Research & Communications activities, including methodological improvements
• Engages in inspection readiness support including provision of data to project managers for metrics and activity tracking
• Develops a culture of courage, excellence, equity and joy within the team including regular communications, coaching, and mentoring of the team as required.
• Makes decisions based on clinical experience
• Assesses the suitability of biopharmaceutical products on typical physician practice within various health systems, hospital and non-hospital patient care facilities.

Technical Skill Requirements

• Understanding of aggregate safety data and signal assessment methodology, and ability to perform benefit-risk assessments.
• Ability to perform safety data review, safety data assessment, Clinical safety signal identification, risk identification and risk management
• Understanding of the scientific basis for therapies and drug-induced diseases
• Ability to lead a cross functional team and lead through example, commitment and enthusiasm in a matrixed environment with minimal oversight
• 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
• Effective verbal and written communication skills.

Qualifications

• Medical Degree (MD, DO) or equivalent required
• 4+ years' experience to include medical (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 
• Disease area-specific knowledge in Oncology preferred
• 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 an 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
• Demonstrated leadership in day-to-day activities, including strong interpersonal and collaborative 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:  This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week.

The annual base salary for this position ranges from $219,800.00 to $366, 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.

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.

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Medical

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