Medical Safety Officer - Solid Tumors Oncology

Essential Job Duties and Responsibilities

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.

The MSO will report to the Therapeutic Area (TA) Safety Head and oversee the safety assessment of assigned drugs within the TA that are marketed and/or in clinical development. Collaborating with relevant functions, the MSO will ensure proactive and timely assessments of safety data to characterize the emerging and known safety profiles and benefit risk of their products within the TA. The MSO will communicate potential and known risks, when appropriate, to TA Safety Head, Chief Safety Officer (CSO), Chief Medical Officer (CMO), Qualified Person for Pharmacovigilance (QPPV), Senior Management, Health Authorities (HA), prescribers and/or patients. In compliance with legal and regulatory requirements, the MSO will also 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. SMT responsibilities include safety surveillance (including signal detection) and risk management activities [including Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategy (REMS)], as well as other activities related to managing the safety profile of 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 including:
• Risk management plans.
• Safety development plan.
• Clinical Trial Protocols.
• Informed Consent Forms (ICF).
• Safety Sections of Investigator’s Brochure (IB) and IB addenda.
• Clinical Study Reports (CSR).
• Annual Safety Reports (ASR).
• Integrated Safety Summary (ISS) and Summary of Clinical Safety (SCS) for NDA/BLA/MAA filings.
• Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR).
• Health authority queries.
• Core Data Sheets (CDS).
• 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. This will include:
• Defining the safety question or issue requiring medical safety assessment.
• Developing the strategy for the safety review and analysis.
• Interpreting results and determining the medical importance of a question or issue.
• Reviewing and approving (i.e., signatory) medical assessment reports (e.g., ad hoc safety reports).
• 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.
• Assist 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

This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.

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.

• 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.

Required Technical Knowledge and Skills:

• Ability to lead global cross-functional teams effectively and strategically.

• Connect, collaborate, and build consensus across relevant functions.

• Ability to think strategically, have a global mindset, big picture orientation, Ability to see the context of the entire situation, understand implications to the business.

• Ability to critically evaluate safety data from multiple sources (clinical trials, environment, literature, etc.), assess clinical importance and potential strategic impact of the data and present the findings clearly in both written and oral communications.

• Experience and knowledge of Good Clinical Practices and Pharmacovigilance regulatory requirements in US, the EU and globally, the conduct of clinical trials and for the appropriate contributions to regulatory filings, PV documents and risk management plans.

• Able to plan work to meet deadlines and effectively handle multiple priorities.

• Excellent verbal and written communication skills, including formal presentation skills. Written skills as evidenced by publication and journal articles are also desirable.

• Fluent in written and spoken English.

• Proficiency in Word and PowerPoint is desired.

Other requirements

• Not applicable