P2603 - Associate Safety Physician

Debiopharm·
Lausanne, Vaud
1mo ago
Full-timeEntryClinical Safety & PharmacovigilanceOncologyMD

Description

<p><strong>At Debiopharm, every step we take is guided by one purpose: Improving the lives of people affected by cancer and infectious diseases. As a privately-owned Swiss biopharmaceutical company, we're driven by science, but above all, by the people behind every treatment - the patients and their families. Through our unique "development only" model, we bring forward promising therapies and transform them into treatments that can reach those who need them most, faster. </strong></p><p></p><p><strong>If you're ready to make a real impact - this is your moment.</strong></p><p></p><p>We are currently looking for a motivated and collaborative professional to join our&nbsp;Clinical&nbsp;Safety &amp; Pharmacovigilance team&nbsp;based at our Headquarters in Lausanne, Switzerland as&nbsp;</p><p>&nbsp;</p><h3><strong>Associate Safety Physician&nbsp;- P2603&nbsp;</strong></h3><p>&nbsp;</p><p>In this role, you will actively manage and evaluate&nbsp;Safety Data&nbsp;for products in development, working under the guidance of the Executive Safety Physician or the Head of Clinical Safety.&nbsp;</p><p>&nbsp;</p> <p><strong>Your&nbsp;Mission&nbsp;</strong></p><ul><li>Medical Safety Oversight:&nbsp;Manage project safety profiles and conduct individual/aggregate medical reviews within the safety database.&nbsp;</li></ul><ul><li>Clinical Support:&nbsp;Provide expert medical input for study protocols, Investigator Brochures (IBs), and Development Safety Update Reports (DSURs).&nbsp;</li></ul><ul><li>Signal Detection &amp; Surveillance:&nbsp;Lead ongoing safety monitoring and signal detection, particularly during early-phase clinical trials.&nbsp;</li></ul><ul><li>Cross-Functional Collaboration:&nbsp;Partner with Clinical, Regulatory, and Biostatistics teams to ensure clinical programs support robust safety assessments.&nbsp;</li></ul><ul><li>Stakeholder Representation:&nbsp;Represent Safety in study teams, internal task forces, and external meetings like IDMCs.&nbsp;</li></ul><ul><li>Regulatory &amp; Compliance:&nbsp;Contribute to safety sections of IND/NDA submissions and&nbsp;maintain&nbsp;inspection readiness for audits/inspections.&nbsp;</li></ul><p>&nbsp;</p><p><em>More than a checklist of skills,&nbsp;we’re&nbsp;looking for someone who shares our commitment to science with purpose.&nbsp;</em></p><p>&nbsp;</p><p><strong>Your&nbsp;profile&nbsp;</strong></p><ul><li>Medical Credentials:&nbsp;Medical Doctor (MD) with 2/3years of clinical/pharma experience or a Physician with research fellowship experience.&nbsp;</li></ul><ul><li>Technical Expertise:&nbsp;Proven ability in medical review, data analysis, and safety surveillance within clinical studies.&nbsp;</li></ul><ul><li>Regulatory Knowledge:&nbsp;Solid foundational understanding of GCP and Pharmacovigilance (PV) principles.&nbsp;</li></ul><ul><li>Communication Mastery:&nbsp;Excellent English verbal and medical writing skills, with the ability to simplify complex terminology.&nbsp;</li></ul><ul><li>Matrix Efficiency:&nbsp;Ability to thrive in a high-stress matrix environment, collaborating effectively across all organizational levels.&nbsp;</li></ul><ul><li>Operational Excellence:&nbsp;Strong problem-solving skills with&nbsp;a track record&nbsp;of meeting deadlines and&nbsp;maintaining&nbsp;high quality standards.&nbsp;</li></ul> <p><strong>What&nbsp;we&nbsp;Offer:&nbsp;</strong></p><ul><li>Being part of a company where innovation, collaboration, and impact&nbsp;aren’t&nbsp;just values —&nbsp;they’re&nbsp;how we work every day&nbsp;</li></ul><ul><li>Partner with teams across disciplines, at the forefront of oncology and anti-infective development&nbsp;</li></ul><ul><li>An inclusive and respectful workplace — proud to be Equal-Pay certified&nbsp;</li></ul><ul><li>Grow in a culture that values people, purpose, and performance&nbsp;</li></ul><ul><li>A chance to grow, share, and shape the future of healthcare&nbsp;</li></ul><p>&nbsp;</p><p><strong>What to Expect in the Recruitment Process:&nbsp;</strong></p><p>If your application is selected,&nbsp;you’ll&nbsp;be invited to interviews with Talent Acquisition and the Hiring Manager via Teams, followed by a&nbsp;panel&nbsp;interview and reference checks. Communication is&nbsp;handled&nbsp;via&nbsp;Workable—check your spam folder for emails from&nbsp;*@outbound.workable.com.&nbsp;</p><p>&nbsp;</p><p>Please contact our HR Department prior to&nbsp;submitting&nbsp;any profiles. We cannot accept unsolicited applications from agencies or recruiters.&nbsp;</p><p>&nbsp;</p>

Requirements

<p><strong>Your&nbsp;Mission&nbsp;</strong></p><ul><li>Medical Safety Oversight:&nbsp;Manage project safety profiles and conduct individual/aggregate medical reviews within the safety database.&nbsp;</li></ul><ul><li>Clinical Support:&nbsp;Provide expert medical input for study protocols, Investigator Brochures (IBs), and Development Safety Update Reports (DSURs).&nbsp;</li></ul><ul><li>Signal Detection &amp; Surveillance:&nbsp;Lead ongoing safety monitoring and signal detection, particularly during early-phase clinical trials.&nbsp;</li></ul><ul><li>Cross-Functional Collaboration:&nbsp;Partner with Clinical, Regulatory, and Biostatistics teams to ensure clinical programs support robust safety assessments.&nbsp;</li></ul><ul><li>Stakeholder Representation:&nbsp;Represent Safety in study teams, internal task forces, and external meetings like IDMCs.&nbsp;</li></ul><ul><li>Regulatory &amp; Compliance:&nbsp;Contribute to safety sections of IND/NDA submissions and&nbsp;maintain&nbsp;inspection readiness for audits/inspections.&nbsp;</li></ul><p>&nbsp;</p><p><em>More than a checklist of skills,&nbsp;we’re&nbsp;looking for someone who shares our commitment to science with purpose.&nbsp;</em></p><p>&nbsp;</p><p><strong>Your&nbsp;profile&nbsp;</strong></p><ul><li>Medical Credentials:&nbsp;Medical Doctor (MD) with 2/3years of clinical/pharma experience or a Physician with research fellowship experience.&nbsp;</li></ul><ul><li>Technical Expertise:&nbsp;Proven ability in medical review, data analysis, and safety surveillance within clinical studies.&nbsp;</li></ul><ul><li>Regulatory Knowledge:&nbsp;Solid foundational understanding of GCP and Pharmacovigilance (PV) principles.&nbsp;</li></ul><ul><li>Communication Mastery:&nbsp;Excellent English verbal and medical writing skills, with the ability to simplify complex terminology.&nbsp;</li></ul><ul><li>Matrix Efficiency:&nbsp;Ability to thrive in a high-stress matrix environment, collaborating effectively across all organizational levels.&nbsp;</li></ul><ul><li>Operational Excellence:&nbsp;Strong problem-solving skills with&nbsp;a track record&nbsp;of meeting deadlines and&nbsp;maintaining&nbsp;high quality standards.&nbsp;</li></ul>
Debiopharm

Debiopharm

CDMO

Contract Development & Manufacturing

LocationSwitzerland - Lausanne
Employees1-50
Open Jobs6
OncologyInfectious DiseasesEndocrinologyCardiovascularNephrology
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