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Senior Pharmacovigilance Specialist, Clinical Safety

Company: Galderma S.A.
Location: Bridgewater
Posted on: February 25, 2021

Job Description:

Senior Pharmacovigilance Specialist, Clinical Safety Apply Now Job Family Pharmacovigilance City Bridgewater State/Province New Jersey Country United States Contract Type Full Time Posting Start Date 28-Jan-2021 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 Senior Pharmacovigilance Associate, Clinical Safety is responsible for ensuring pharmacovigilance operational aspects of interventional clinical studies (corporate level and interventional local/regional Phase 4 studies) are well managed. This position will act as key contact point for the Clinical groups and vendors for operational aspects and will set up and maintain efficient processes. The Senior PV Associate will collaborate with the PV Risk Minimization Physician for medico-scientific safety aspects related to clinical studies. Job Responsibilities

  • Review the safety sections of study protocols, contribute to the study safety management plan
  • Review and update the safety sections of clinical study reports and manuscripts for studies
  • Plan, set-up, and participate in safety review meetings for clinical studies
  • Contribute to the writing/review of the department quality documents (e.g. SOPs, working guidance)
  • Contribute to PSURs/PBRERs for marketed products that are being tested in clinical trials
  • Contribute to dossier submission (e.g. Clinical Overviews, Clinical Evaluation Reports, Summary of Clinical Safety) and other relevant reports for regulatory submissions and renewals
  • Coordinate and contribute to the preparation of DSURs and other aggregate safety reports required by Health Authorities, according to developmental product assignment/responsibilities
  • Coordinate and contribute to the development of Risk Management Plans and manage the contribution of a Medical Writer
  • Provide input to the update of the Investigator's Brochure (especially the Reference Safety Information) and provide input into subject informed consent documents
  • Provide applicable input into Safety Data Exchange Agreements and act as contact point for clinical safety activities for partners
  • Support the Director, Clinical Safety with various project-related tasks, especially those concerning the Prurigo Nodularis indication of nemolizumab
  • Other duties as assigned
  • Pharmacist or other HCP, i.e. Registered Nurse, Doctor, Veterinarian, Dentist
  • Bachelor's degree is required in Life Sciences or other relevant field
  • Master's degree or PhD preferred
  • At least seven (7) years in Clinical Drug Safety in the pharmaceutical/medical device industry with at least the last 3 years in a Senior PV Associate role
  • Knowledge of international (FDA, EU, ICH) regulations related to safety in clinical studies, required
  • MS Office (Word, Excel, PowerPoint)
  • eDocument Management
  • Prior experience with Training and CAPAs
  • Proficiency with PV computerized systems
  • There may be the occasional requirement to travel internationally, up to a maximum of 4 times per year. Other Important Information Employer's Rights: This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. You will be evaluated in part based upon your performance of the tasks listed in this job description. The employer has the right to revise this job description at any time. This job description is not a contract for employment, and either you or the employer may terminate employment at any time, for any reason. In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Keywords: Galderma S.A., Trenton , Senior Pharmacovigilance Specialist, Clinical Safety, Healthcare , Bridgewater, New Jersey

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