Medical Safety Officer, Immunology

• Job Function: Product Safety
• Job Sub Function: Product Safety Risk Management MD
• Job Category: Scientific/Technology
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Locations: Allschwil, Basel-Country, Switzerland, Beerse, Antwerp, Belgium, Diegem, Flemish Brabant, Belgium, Horsham, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description

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 Portfolio Safety Head (PSH) and oversee the safety assessment of assigned drugs within the portfolio 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 Portfolio.

The MSO will communicate potential and known risks, when appropriate, to Portfolio Safety Head, 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.

Responsibilities

• Strategically lead Safety Management Teams (SMT) for assigned products, and oversee safety surveillance and risk management activities such as signal detection, Risk Management Plan (RMP), and Risk Evaluation and Mitigation Strategy (REMS).
• Provide medical and scientific expertise as the GMS representative on the Compound Development Team (CDT) and Clinical Teams.
• Anticipate safety concerns and influence other functions, including Clinical teams, to minimise patient impact through active participation in clinical protocol design.
• Act as 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 and Informed Consent Forms (ICF).
• Safety sections of Investigator's Brochure (IB) and addenda.
• Clinical Study Reports (CSR).
• Annual Safety Reports (ASR), Integrated Safety Summary (ISS), 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 to GMS Leadership Team, CMO, and 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 evaluating Licensing & Acquisition opportunities.
• Provide medical oversight to contractors and non-physician staff preparing written safety evaluations, including:
• Defining the safety question or issue requiring 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 medical assessment reports (e. g., ad-hoc safety reports).
• Work across GMS TAs to align and improve common processes, including providing strong leadership and a harmonised approach across clinical teams for safety data collection, assessment, and safety-related processes.
• 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.
• Minimum Qualification
• Physician (MD or equivalent) with 2-5 years of pharmacovigilance experience or other relevant experience (e. g., clinical research, medical affairs, clinical).
• Board Certified/Board Eligible or equivalent preferred.
• Medical specialization preferred.
• Demonstrated skills in clinical medicine with at least 1 year of clinical practice experience.
• Demonstrated knowledge of drug development principles, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, safety assessment of drugs on the market and in development, and global safety regulations highly preferred.
• Ability to influence, negotiate and communicate with internal and external stakeholders.
• Experience with Health Authority presentations preferred.
• Required Technical Knowledge and Skills
• Ability to lead global cross-functional teams effectively and strategically.
• Build consensus across relevant functions.
• Strategic thinking, global mindset, big-picture orientation, and understanding of business implications.
• Critically evaluate safety data from multiple sources and present findings clearly in written and oral communications.
• Experience and knowledge of Good Clinical Practices and Pharmacovigilance regulatory requirements in US, EU and globally, conduct of clinical trials and contributions to regulatory filings, PV documents and risk management plans.
• Plan work to meet deadlines and handle multiple priorities.
• Excellent verbal and written communication skills, including formal presentations.
• Fluent in spoken and written English.
• Proficiency in Word and Power Point desirable.
• Preferred Skills
• Clinical Operations, Compliance Management, Compliance Risk, Consulting, Design Mindset, Developing Others, Leadership, Medicines and Device Development and Regulation, Operational Excellence, Quality Control (QC), Research Ethics, Risk Management, Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting, Standard Operating Procedure (SOP), Succession Planning, Surveillance.
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