SAFETY RISK LEAD

As a SAFETY RISK LEAD for MEDICAL DEVICES & COMBINATION PRODUCTS you will have the following 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.
• 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.
• 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.
• 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.
• 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.
• DDD Specific responsibilities can include:
  • Maintenance of Design History Files
  • Review of Human Factors strategy, clinically relevant protocols and summary reports
  • Accountability for the Benefit/Risk Analysis of DDD
  • Accountability for Safety impact assessment and Hazard Analysis of DDD including determining potential occurrence and severity of harm
  • Responsible for review and approval of DDD risk management summary reports
  • Responsible for the SSRM of DDD including input to Labeling and IFU safety

• Education: MD (physician) degree required.
• Drug Delivery Device specific knowledge is required.
• Medical Devices experience and Drug Delivery Device specific knowledge is 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.    
• 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.
• You are willing to travel regurarly to the UK.

You will receive an attractive salary package with interesting fringe benefits, all in an exciting work environment where you have the ample opportunity to grow and to develop.

Bezoek www.select-jobs.be voor meer informatie over de vacature SAFETY RISK LEAD of solliciteer online op de vacature SAFETY RISK LEAD.

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