Safety Risk Lead (SRL)

Primary Responsibilities
• 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:
o Maintenance of Design History Files
o Review of Human Factors strategy, clinically relevant protocols and summary reports
o Accountability for the Benefit/Risk Analysis of DDD
o Accountability for Safety impact assessment and Hazard Analysis of DDD including determining potential occurrence and severity of harm
o Responsible for review and approval of DDD risk management summary reports
o Responsible for the SSRM of DDD including input to Labeling and IFU safety

Technical Skill Requirements
• 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.

Qualifications (i.e., preferred education, experience, attributes)
• 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.