Global Medical Safety Lead

This is a fully remote position, open to applicants in Belgium, +2 more countries.

📋 Description

• Lead and conduct assessments of medical safety data for designated products.

• Formulate and implement safety signaling and benefit-risk management strategies.

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

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

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

• Direct cross-functional evaluations of both existing and emerging aggregate safety data.

• Contribute to safety governance frameworks and activities.

• Provide input on safety for global regulatory submission documents.

• Prepare and review safety sections within clinical and regulatory documents.

• Assist in responding to inquiries from regulatory authorities.

• Lead the preparation of periodic safety reports, ensuring their quality and consistency.

• Supervise medical evaluations of individual case safety reports.

• Confirm the criteria and content necessary for expedited reporting and unblinding.

• Lead or contribute to the preparation of safety information and presentations for the Data Safety Monitoring Board.

• Provide medical safety insights during internal audits and regulatory inspections.

• Assist in the development and updates of pharmacovigilance SOPs and controlled documents.

• Support training on adverse event reporting and pharmacovigilance awareness initiatives.

• Aid in the preparation of pharmacovigilance agreements with clinical development or commercial partners.

• Participate in cross-functional teams and initiatives.

• Report directly to the Head of Global Patient Safety.

⛳️ Requirements

• MD degree or equivalent is mandatory.

• Minimum of 15 years of relevant experience in the pharmaceutical or biotech industry.

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

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

• Solid understanding of relevant pharmacovigilance regulatory requirements and guidance documents.

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

• Experience in authoring complex documents and contributing to regulatory submissions.

• Familiarity with adverse event reporting systems.

• Strong scientific and analytical capabilities.

• Ability to manage multiple tasks simultaneously and achieve results in a fast-paced environment.

• Capability to lead, motivate, influence, and collaborate with multidisciplinary teams.

• Excellent presentation skills and the ability to clearly communicate complex issues.

• Proficient in Microsoft Office applications.

• Fluent in both written and spoken English.

• Candidates must reside in Belgium, Switzerland, or the United States (EST time zone).

• Experience in epidemiology, biostatistics, clinical development, or medical affairs is advantageous.

• Global experience is an added benefit.

🏝️ Benefits

• Short-term incentives program.

• Long-term incentives program.

• Equal consideration for employment without discrimination.

• Inclusive work environment.