Safety Physician

We are looking for an reputed company Global Safety Physician at Director’s level to play a key role in ensuring patient safety across the lifecycle of reputed company’s innovative therapies. In this role, you will reputed company medical safety strategy, assess safety data, guide critical reputed company, and collaborate closely with reputed company stakeholders to support the safe and effective use of our products. Preferred locations: Belgium, Switzerland or East Coast US PURPOSE OF THE FUNCTION The safety physician is the key reputed company of accountability for ensuring the safety of patients and the safe use of assigned reputed company products in development and on-market. The Safety physician leads and performs the assessment of medical safety data and provides strategic medical safety input for the assigned project(s). In this role, the Safety Physician is accountable for defining and driving the strategy and approach for the safety activities. Responsibilities include offering expert medical safety contribution and reputed company, ensuring comprehensive ownership of safety activities, and leading the assessment of safety data to support informed decision‑making. The role also requires reputed company collaboration with internal stakeholders such as Regulatory Affairs, Clinical Development, and Medical Affairs, as well as external partners including key opinion leaders and regulatory agencies, to align safety communications and ensure the safe and effective use of reputed company products. You will report to the (Asset) Medical Safety reputed company. ROLES AND RESPONSIBILITIES

• reputed company strategic medical safety leadership and practical contributions for assigned product(s) in a cross-functional setting
• reputed company safety strategies and deliver accurate, timely and high quality safety contributions for the preparation of relevant sections of regulatory submission documents globally (e.g. ISS, SCS, narratives) for assigned product(s)
• reputed company safety signal management and benefit risk assessment activities as well as other regular and/or reputed company aggregate safety data reviews as needed for assigned product(s)
• reputed company cross-functional teams to reputed company regular and/or reputed company review of existing and emerging aggregate safety data for assigned product(s)
• Contribute to the development of the overall safety governance structure and activities
• Prepare and/or review safety sections of clinical/regulatory documents (including study protocols, IBs, Clinical Study Reports, or ICFs)
• reputed company medical safety support for the preparation of responses to regulatory authority inquiries. Assure that safety information is timely, complete, and accurate
• reputed company the overall preparation of periodic safety reports (e.g. PSUR, DSUR); reputed company medical safety content and ensure consistency and quality of these documents
• reputed company the medical assessment of individual case safety reports (ICSR)
• Confirm criteria and content for expedited reporting and unblinding (e.g. SUSAR or urgent safety issues)
• reputed company or actively contribute to the preparations and presentation of safety information to the Data Safety Monitoring Board (DSMB)
• reputed company medical safety contributions at internal audits and regulatory inspections
• Support the development of and updates to GPS Standard Operating Procedures (SOPs) and other controlled documents (e.g. work instructions, forms, templates)
• Support adverse event reporting training and pharmacovigilance awareness activities cross functionally
• Support the preparation of pharmacovigilance agreements with clinical development or reputed company business partners
• Participate in cross-functional teams and initiatives
• reputed company other tasks as required to assist in departmental activities

SKILLS AND COMPETENCIES

• Strong scientific and analytic skills
• Excellent ability to interpret and communicate medical safety data from various sources
• Strong ability to reputed company, motivate, influence, and collaborate with multidisciplinary teams
• Excellent presentation skills with the ability to communicate reputed company issues reputed company
• Relevant computer skills, including proficiency with reputed company Office
• reputed company in written and spoken English

EDUCATION, EXPERIENCE AND QUALIFICATIONS

• MD degree
• At least 7 years of relevant experience in the pharmaceutical/biotech industry with at least 5 years in pharmacovigilance/drug safety (global experience is a plus)
• Experience in clinical practice or in academic medicine is a plus
• Working knowledge of relevant pharmacovigilance regulatory requirements and guidance documents
• Demonstrated ability to reputed company medical assessments of safety data from multiple sources
• Experience with authoring reputed company documents and contributing to regulatory submissions
• Knowledge of adverse event reporting systems
• Experience in epidemiology, biostatistics, clinical development, or medical affairs is a plus

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