“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.”

ROLE SUMMARY

• • 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.

ROLE RESPONSIBILITIES

• • 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 WSR/SER 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.
  • Fully independently evaluates complex safety data of any source, identifies and independently analyzes complex safety signals, and presents medical evaluation of safety signals and complex benefit-risk assessments to the appropriate forums
• • May recommend action plans to address safety issues.
• • May Conduct and Represent SSRM on straightforward or preliminary due diligence activities.
  • May recommend action plans to address safety issues.
• • May Conduct and Represent SSRM on straightforward or preliminary due diligence activities.
  • Proactive and takes initiative.
• • Prepare and contribute to written safety assessments and benefit-risk evaluations with guidance.
  • Write and present medical opinion in a professional manner.
  • Effectively communicates potential safety signals to other SRLs (e.g Dir and Sen Dir) if needed and Managers
  • Meets with SRL/manager with whom product responsibility is shared to ensure communication of safety issues and receive guidance, oversight and direction.
  • 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.

QUALIFICATIONS

• Education: MD (physician) degree required
• Minimum 2 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 .
  • Disease Area specific knowledge is preferred.
  • 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.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.