Safety Risk Lead (SRL) - MD - Director


The Safety Risk Lead (SRL) will perform proactive Safety Surveillance (SS) and Risk Management with focus on signal detection and evaluation, risk assessment and safety risk minimization.

  • Act as a Point of Contact for Safety in the Asset Teams, ensuring a unified communication on safety matters and representing WWS position(s) on safety
  • Provides disease area specific pharmacovigilance expertise, and applies this to various business unit products assigned to the SRL operating from a SSRM DA-Cluster. Each SSRM DA-Cluster functions as a "Centre of Excellence"
  • Ensures consistency of Safety Risk Messaging for a particular product or class of products, across multiple indications/BUs within the many safety reports and communications for that product. Providing suitable summaries of product risks to summary document authors where appropriate, for example providing medical content/B-R statements and overall risk messaging of the safety profile to WMS/PSSR Authors
  • Performs ad hoc special scholarly Safety Surveillance & Risk Management activities, rapidly, to meet specific needs in the BUs, such as RRT deliverables/emerging safety issue white papers/product Due Diligence Assessments
  • Identifies opportunities for Consistency and Standards for Safety Surveillance & Risk Management approaches and processes within a DA-Cluster and across BUs, and supporting the piloting and implementation of such
  • Innovates, champions and implements novel approaches to Safety Surveillance & Risk Management across BUs: engages in Continuous Improvement initiatives, Safety Sciences Research & Communications activities, including methodological improvements
  • Engages in inspection readiness and support. Provision of data to project managers for metrics and activity tracking
  • Frequently independently performs evaluation of all sources of safety data, identifies and independently analyzes safety signals, and presents evaluation of safety signals and benefit risk assessments to the appropriate forums
  • Contributes SSRM perspective and subject matter expertise to all relevant areas of risk management plans, expert reviews, Health Authority Queries and other documents as required
  • Prepares basic action plans independently to address risk and benefit-risk issues. Handles more advanced/complex plans with direction/coaching
  • Conducts and Represents SSRM on due diligence activities.
  • Provides guidance and/or oversight to SSRM colleagues on safety issues. Provides formal and informal education to other SSRM colleagues on key safety and pharmacovigilance topics
  • Represent WSS on safety and benefit-risk issues to external groups including regulatory authorities and business partners
  • Contributes to review and development of intradepartmental policies and procedures as appropriate
  • Initiates, conducts and chairs Risk Management Committee, P-BRC (co-chair) and CWGs with minimal oversight
  • Prepares and contributes to written safety assessments and benefit-risk evaluations
  • Reviews safety assessments/evaluations/contributions prepared by senior manager SRLs and other safety colleagues
  • Completes all assigned activities with minimal guidance.
  • Makes decisions based on clinical experience
  • Utilizes knowledge of integrated body systems' pathophysiology to evaluate the impact of product issues
  • Assesses the suitability of biopharmaceutical products on typical physician practice within various health systems, hospital and non-hospital patient care facilities
  • Ensures products fulfil quality medical care
  • For early development programs serve as a safety consultant to Clinical


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.
  • Education: MD (physician) degree required
  • Minimum 5 years of: 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 experience required
  • Oncology Disease Area specific knowledge is preferred, including understanding of Oncology drug development
  • Thorough understanding of Safety Risk Management internal and external environment, including applicable regulations and guidances
  • Clinical development and post-marketing experience to have an understanding of safety context across the drug lifecycle
  • Demonstrated leadership in day-to- day activities and collaborative skills
  • Demonstrated self-awareness and interpersonal skills for successful execution of the role
  • Demonstrated ability to 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
  • Relevant knowledge of Pharmaceutical Company organizational structure, policies, and practices, as applicable to safety Risk Management

Technical Skills, (plus knowledge, experience and ability in):
  • Safety data review, Safety data assessment, Clinical Safety signal identification, risk identification and risk management. Understands aggregate safety data and signal assessment, and performs benefit-risk assessments. From a medical perspective, independently evaluates safety data, identifies and independently analyzes safety signals, and presents the medical evaluation of safety signals to the appropriate forums
  • Matrix safety team leadership
  • Understanding of the scientific basis for therapies and drug-induced diseases. Effective interactions with key external subject matter experts including regulatory authorities

  • Standard travel and working flexible hours can be required ad-hoc.

Other Job Details:

Last Date to Apply for Job: September 24th, 2021

Additional Location Information: New York, NY; Collegeville, PA; Groton, CT; Peapack, NJ


Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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EEO & Employment Eligibility

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