Global Medical Safety Lead

This is a fully remote position, open to applicants in Belgium, +1 more country.

📋 Description

• Oversee and conduct medical safety data evaluations for designated products

• Formulate and implement strategies for safety signalling and benefit-risk management

• Engage with internal stakeholders as well as external key opinion leaders and regulatory bodies

• Deliver strategic medical safety leadership and practical input in cross-functional environments

• Manage safety signals, conduct benefit-risk assessments, and review aggregate safety data

• Facilitate cross-functional evaluations of both existing and new aggregate safety data

• Contribute to the structures and activities of safety governance

• Prepare safety-related content for global regulatory submission documents

• Draft and review safety sections in clinical and regulatory documentation

• Assist in responses to inquiries from regulatory authorities

• Lead the preparation of periodic safety reports while ensuring document quality and consistency

• Supervise medical evaluations of individual case safety reports

• Validate criteria and content for expedited reporting and unblinding processes

• Lead or assist in preparing safety information for Data Safety Monitoring Boards

• Provide medical safety contributions during audits and regulatory inspections

• Assist in the development and updating of pharmacovigilance standard operating procedures and controlled documents

• Support training on adverse event reporting and pharmacovigilance awareness initiatives

• Aid in the preparation of pharmacovigilance agreements with partners

• Participate in cross-functional teams and initiatives

⛳️ Requirements

• MD degree or equivalent is mandatory

• Minimum of 15 years of pertinent experience in the pharmaceutical or biotech fields

• At least 5 years of experience in pharmacovigilance or drug safety

• A minimum of 1 year of experience in clinical practice or academic medicine

• Proficient understanding of relevant pharmacovigilance regulatory requirements and guidance

• Proven ability to conduct medical assessments of safety data from diverse sources

• Experience in authoring complex documents and contributing to regulatory submissions

• Knowledgeable in adverse event reporting systems

• Strong scientific and analytical capabilities

• Ability to manage multiple tasks simultaneously and achieve results in a dynamic environment

• Exceptional ability to lead, inspire, influence, and collaborate with multidisciplinary teams

• Excellent presentation skills with the ability to clearly communicate complex issues

• Relevant computer skills, particularly proficiency in Microsoft Office

• Proficient in written and spoken English

🏝️ Benefits

• Short-term incentives program

• Long-term incentives program

• Equal opportunity for employment without discrimination

• Inclusive work environment