Safety Physician - Clinical Studies

Safety Physician - Clinical Studies

Galderma

Lausanne, Switzerland

Description

For our Global Quality and Pharmacovigilance Organization based in Lausanne, Switzerland, we are currently looking for a safety physician- clinical studies.

In this challenging and dynamic role, you will be part of the Global Quality and Pharmacovigilance Organization and report to the Head of Pharmacovigilance Risk Management.

The core mission of the Global Quality department is as follow:

  • Protect patients and customers of Galderma products from safety issues (from Innovation to Solution);
  • Promote safe and effective use of Galderma products;
  • Lead the scientific and operational activities - across Galderma - relating to the detection, assessment, understanding and prevention of adverse effects;
  • Ensure customers satisfaction as well as regulatory compliance in all markets.

Within the department, your specific mission is to:

  • Ensure that the benefit risk assessment is current for a specific set or category of Galderma products and that any change is handled as per Galderma’s decision-making principles;
  • Be accountable, in a matrix organization, for the Benefit and Risk activities including signal detection, risk management, risk mitigation plans, safety analyses in aggregate reports, medical review of ICSR (Individual Case Safety Report) as needed;
  • Be responsible of the scientific review of safety related information in study protocols, study reports, Investigator Brochure, product labelling, Aggregate Reports as well as in responses to specific questions from Health Authorities;

Responsibilities

  • Propose measures aiming at minimizing risks during clinical development; release/update the Development Risk Management Plans (DRMPs).
  • For assigned compounds, interact with internal and external stakeholders to ensure monitoring of safety profile, signal validation & signal evaluation, and propose appropriate risk management and risk minimization measures;
  • Review/provide input to Aggregate Reports (e.g. DSUR, PSUR, PBRER);
  • Review/provide input to (development) Risk Management Plans (RMP);
  • Contribute to answers to safety-related questions from Regulatory agencies and internal/external stakeholders;
  • Contribute to Investigators/KOLs meetings for safety-related aspects/questions;
  • Contribute to IDMC (Independent Data Monitoring Committee) meetings Contribute to Due Diligences, as needed;
  • Lead on-going safety data review during clinical trials through Safety Plans and Safety Review Meetings;
  • Escalate and present safety issues at company governance bodies;
  • Medical review of ICSR;
  • Ensure effective collaboration with the Strategy & Innovation Group, Clinical Development group, and the other stakeholders;

Required Experience

  • Medical doctor;
  • Additional degree in clinical pharmacology and/or pharmacovigilance/drug safety and/or public health and/or epidemiology;
  • At least 12years of pharmacovigilance experience in pharmaceutical/medical device companies at an international level;
  • Significant experience and knowledge of international clinical development and post marketing regulations applicable to drugs; knowledge of requirements medical devices is an extra;
  • Interactions with Health Authorities in the US, EU and other geographies to address safety medical questions related to safety in clinical studies (e.g. Summary of Clinical Safety, Clinical Overview, RMP);
  • Sound knowledge of the global pharmacovigilance and safety requirements for non-clinical and clinical development, registration process and post-marketing;
  • Experience in analyzing and managing significant safety issues across product life cycle with a focus on drugs under clinical development;
  • Be able to identify risks and propose mitigation actions in complex and critical situations and the ability to a multifunctional team and achieve deliverables within agreed timelines.
  • People management experience
  • Ability to work independently, to manage stress and to adapt in a fast changing business environment
  • Fluent in English

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© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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