Medical Director

📋 Description

• Provide strategic leadership in medical safety and hands-on support for designated products within a cross-functional setting.

• Formulate safety strategies and ensure the provision of accurate, timely, and high-quality safety input for global regulatory submission documents (e.g., ISS, SCS, narratives) for designated products.

• Perform safety signal detection and benefit-risk assessment activities, along with routine and ad-hoc aggregate safety data reviews for designated products.

• Facilitate cross-functional discussions and evaluations of both existing and emerging aggregate safety data for designated products.

• Contribute to the enhancement of the overall safety governance framework and related initiatives.

• Draft and/or review safety sections of clinical and regulatory documents (including study protocols, IBs, Clinical Study Reports, and ICFs).

• Provide medical safety expertise in addressing regulatory authority inquiries and ensure safety information is comprehensive, accurate, and submitted promptly.

• Lead the preparation of periodic safety reports (e.g., PSUR, DSUR), ensuring consistency, quality, and appropriate medical safety content.

• Supervise the medical review and assessment of individual case safety reports (ICSRs).

• Validate reporting criteria and content for expedited reporting and unblinding activities (e.g., SUSARs or urgent safety matters).

• Lead or assist in the preparation and presentation of safety data for Data Safety Monitoring Board (DSMB) meetings.

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

• Aid in the development and maintenance of GPS Standard Operating Procedures (SOPs) and other controlled documents (e.g., work instructions, forms, templates).

• Support adverse event reporting training and cross-functional pharmacovigilance awareness initiatives.

• Assist in the preparation and review of pharmacovigilance agreements with clinical development and commercial partners.

• Engage in cross-functional initiatives and project teams.

• Undertake additional responsibilities as necessary to support departmental goals.

⛳️ Requirements

• MD degree.

• At least 7 years of relevant experience in the pharmaceutical/biotech industry, including a minimum of 5 years in pharmacovigilance/drug safety (global experience preferred).

• Experience in clinical practice and/or academic medicine is regarded as an asset.

• Proficient understanding of global pharmacovigilance regulations and guidance documents.

• Proven capability in performing medical review and assessment of safety data from various sources.

• Experience in authoring complex documents and facilitating regulatory submissions.

• Familiarity with adverse event reporting systems.

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

🏝️ Benefits

• Various annual leave entitlements.

• A range of health insurance offerings tailored to meet you and your family’s needs.

• Competitive retirement planning options to maximize savings and assist with future planning.

• Global Employee Assistance Programme, TELUS Health, providing 24-hour access to a worldwide network of over 80,000 independent specialized professionals dedicated to supporting you and your family’s well-being.

• Life assurance.

• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.