Safety Risk Lead Sr. Director

Pfizer   •  

New York, NY

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 60 days ago

This job is no longer available.

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.
  • Contributes SSRM perspective and advanced subject matter expertise to all relevant areas of risk management plans, expert reviews, Health Authority queries and other documents as required.
  • Prepares advanced/complex action plans to address risk and benefit-risk issues, often requiring cross-functional activity to address safety issues, including complex Risk Management activities.
  • Conducts and Represents SSRM on complex due diligence activities. Coaches others in due diligences
  • Provides guidance and/or oversight to any team member on safety issues.Provides formal and informal education to other SSRM and team colleagues on key safety and pharmacovigilance topics.Coach others in PV/RM.
  • Represents WWS on safety and benefit-risk issues to external groups including regulatory authorities and business partners.
  • Contributes to intra- and interdepartmental policies and procedures and plans for the implementation of new policies and procedures
  • Independently initiates, conducts and chairs RMC, P-BRC (chair) and CWGs.
  • Prepares and contributes to written complex safety assessments and advanced benefit-risk evaluations.
  • Reviews safety assessments/evaluations/contributions prepared by other SRLs and safety other colleagues.
  • Independently prioritizes and completes all activities including multiple complex activities.
  • 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 7 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 – Inflammation & Immunology
  • 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.