Medical Safety Officer - Solid Tumors Oncology

About the role

The Medical Safety Officer (MSO) is a physician with training or experience in Medical Safety, who reports into the Global Medical Safety (GMS) organization and has accountability for assessing the medical safety of Innovative Medicine products and strategically leading cross-functional matrix teams responsible for product safety and benefit risk oversight.

Responsibilities

• Assure proactive and timely assessments of safety data to characterize the emerging and known safety profiles and benefit risk of their products within the TA.
• Communicate potential and known risks, when appropriate, to TA Safety Head, CSO, CMO, QPPV, Senior Management, Health Authorities (HA), prescribers and/or patients.
• Lead, when appropriate, in the design and implementation of risk mitigation strategies to ensure the safe and appropriate use of Innovative Medicine products.
• Strategically lead the Safety Management Teams (SMT) for assigned products.
• Provide medical and scientific expertise as the GMS representative on the Compound Development Team (CDT) and Clinical Teams.
• Anticipate safety concerns and influence other relevant functions including Clinical teams to minimize/mitigate patient impact by active participation in the design of the clinical protocols.
• Be an active partner and core contributor of safety input to key regulatory or clinical documents.
• Effectively communicate (verbally and in writing) important results of medical safety and benefit/risk management evaluations, when necessary, to the GMS Leadership Team, CMO, and the Medical Safety Council (MSC).
• Actively participate and contribute to meetings with Health Authorities and external key opinion leaders.
• Provide medical safety leadership on due diligence teams to evaluate Licensing & Acquisition opportunities.
• Provide medical oversight to contractors and non-physician staff involved in preparing written safety evaluations for their assigned products.
• Work across the GMS TAs to align and improve common processes including providing strong leadership and a harmonized approach across clinical teams for safety data collection, assessment, and safety-related processes and issues.
• Aid in the creation, review and implementation of new SOPs, Work Instructions, guidelines, documents, and other tools pertaining to safety assessment and risk management.
• Lead or actively participate in department-wide initiatives.
• Perform delegate responsibilities for other MSOs and/or SMT Chairs.

Requirements

• Physician (MD or equivalent) with 2-5 years of pharmacovigilance (PV) experience or other relevant experience (e.g., Clinical research, Medical Affairs, clinical) required.
• Board Certified/Board Eligible/equivalent preferred.
• Medical specialization preferred.
• Demonstrated skills in clinical medicine with at least 1 year of clinical practice experience.
• Demonstrated knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and safety assessment of drugs both on the market and in development and global safety regulations highly preferred.
• Ability to influence, negotiate and communicate with both internal and external stakeholders.
• Experience with Health Authority presentations is preferred.

Qualifications

• Minimum Qualification: Physician (MD or equivalent) with 2-5 years of pharmacovigilance (PV) experience or other relevant experience (e.g., Clinical research, Medical Affairs, clinical) required.
• Preferred Qualifications: Board Certified/Board Eligible/equivalent preferred. Medical specialization preferred. Demonstrated skills in clinical medicine with at least 1 year of clinical practice experience. Demonstrated knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and safety assessment of drugs both on the market and in development and global safety regulations highly preferred. Ability to influence, negotiate and communicate with both internal and external stakeholders. Experience with Health Authority presentations is preferred.