Director, Global Pharmacovigilance - Safety Physician

Director, Global Pharmacovigilance - Safety Physician

Teva

Multiple Locations

Your responsibilities

As a Director, Global Pharmacovigilance - Safety Physician you will be part of the Global Pharmacovigilance (PV) and Medical Scientific Unit (MSU) supporting drug safety across the entire Teva portfolio and throughout the product lifecycle.

You will lead activities necessary to determine the safety profile and the characterization, monitoring, and mitigation of risks of assigned products during clinical development and post marketing.

In this role, you will…

• Collaborate with other R&D teams to ensure execution of the safety strategy;
• Contribute to clinical documents: study protocol, IB, informed consent/assent form, clinical study report, integrated summaries of safety, Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests, briefing books, DMC charters, Medical Monitoring Plans, Statistical Analysis Plans, and other relevant safety related clinical documents;
• Lead and chair the cross functional Product Safety Group;
• Perform medical review and assessment of ICSRs for assigned products from clinical trials;
• Be accountable for medical evaluation/interpretation of aggregate safety data of assigned products including signal detection and evaluation, dose escalation evaluations, regulatory safety reports (PSUR, PADER, DSUR), and ad hoc safety review/assessments of assigned and other products;
• Lead risk management activities for assigned products globally and contribute to the preparation of Risk Management Plans (RMPs), REMS, as well as management of these plans throughout product’s life cycle;
• Represent PV on the cross functional Product Label Working Group; Provide PV support and contribution to MAA/NDA/BLA submissions;
• Guide, provide support and train PV scientists across safety surveillance activities such as: medical review, signal detection and risk evaluation activities;
• Collaborate with different functional internal (Medical Affairs, Clinical Development, Quality…) as well as external stakeholders (KOLs, CROs…);
• Support global launch activities for assigned products;
• Perform Signal detection/management related activities including PM AE review, literature review and Health Hazard Assessments as relevant; Perform due diligence on product safety profile of potential new assets.

Your profile

• Medical Doctor/Physician, or equivalent;
• Completion of an accredited Residency/ Specialty program and Board Certified or Eligible;
• Proven experience working in pharmacovigilance and drug safety, as a safety physician;
• Experience in drug development in oncology/immuno-oncology – advantage, or another complex therapeutic area;
• Strong knowledge of FDA and EMA regulations (GVP, GCP);
• Experience with NDA/BLA submissions in the US and MAA in Europe;
• Experience in managing safety issues in pre-and post-marketing environment;
• Proven ability to handle safety surveillance tasks and chair safety committee meetings;
• Strong leadership capabilities and matrix management experience;
• Ability to serve as a subject matter expert within PV and drug safety;
• Outstanding communication skills with an ability to collaborate with different departments and partner with and influence others without direct authority (this role comes with no direct line management responsibility);
• Ability to work cross-functionally within an international team across multiple time-zones;
• Oral and written fluency in English.

Role location

• This role can be based in any EU country or the UK.

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