Safety Risk Lead (SRL) - Non-MD - Director

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 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
  • For early development programs serve as a safety consultant to Clinical


BASIC QUALIFICATIONS

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: DVM (veterinarian), PharmD (pharmacist) or PhD
  • 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
  • Education: MSc degree (Health Care Related) (for non-MD role)
  • Minimum 10 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


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
  • 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

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