Clinical Safety Physician
Galderma Laboratories

Bridgewater, New Jersey

Posted in Health and Safety


This job has expired.

Job Info


Company Overview

Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio of prescription medicines, aesthetics solutions and consumer care products. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit www.galderma.com

Job Description

The Clinical Safety Physician 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. This role is accountable, in a matrix organization, for the Benefit and Risk activities including signal detection, risk management, risk mitigation plans, safety analyses in aggregate reports, and medical review of ICSR as needed. Within this role, you will be responsible for the scientific review of safety related information in study protocols, study reports, Investigator Brochure, CCDS, CSI, product labelling, DSUR/PSUR/PBRER as well as in responses to specific questions from Health Authorities.

Job Responsibilities

Job 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) and (development) Risk Management Plans (RMP)
  • Contribute to answers to safety-related questions from Regulatory agencies and internal/external stakeholders; Investigators/KOLs meetings for safety-related aspects/questions; IDMC (Independent Data Monitoring Committee) meetings; and 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
  • Ensure effective collaboration with the Strategy & Innovation Group, Clinical Development group, and the other stakeholders
  • Contribute to process optimization initiatives and, where needed, set up new activities
  • Provide guidance and medical support to the safety scientists in charge of case processing, without direct reporting line
  • Other duties as assigned

Minimum Requirements
  • Medical Degree (M.D.)
  • Additional degree in clinical pharmacology and/or pharmacovigilance/drug safety and/or public health and/or epidemiology is required
  • 12 or more years of pharmacovigilance experience in pharmaceutical/medical device companies at a global/international level
  • Significant experience and knowledge of international clinical development and post marketing regulations applicable to drugs; knowledge of medical devices requirements is a bonus; Interactions with Health Authorities in the US, EU and other geographies to address medical safety questions related to safety in clinical studies (e.g. Summary of Clinical Safety, Clinical Overview, RMP);
  • Significant late-phase clinical development experience (ideally with biologics), especially with regulatory filings such as NDA, BLA, MAA, NDS
  • 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 pipeline drugs in clinical development
  • Ability to identify risks and propose mitigation actions in complex and critical situations and the ability to influence a cross-functional team and achieve deliverables within agreed timelines
  • Ability to work independently, to take responsibility for own projects/tasks, and to provide key input to difficult or sensitive projects
  • Ability to manage ambiguity and 'conditional' problem solving
  • Fluent in English language - written and oral; Other spoken languages are an asset in building connections with the functions / regions / countries.
  • Proficient in MS Office (Excel, Word, PowerPoint, Outlook, Teams)
  • Proficient in eDocument Management, PV computerized systems



This job has expired.

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