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仕事内容

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 PV Reporting Specialist plays a key role within the PV Risk Management organization at Galderma in ensuring timely safety regulatory submissions, compliance with PV regulation requirements and by gathering quantitative metrics that are extremely relevant for assessing the performance and compliance of a PV system.

Within this role, you will be responsible for delivering global safety reporting services, including expedited and periodic safety reporting to Competent Authorities (CA) and Central Ethics Committees (CEC), for investigational medicinal products (IMPs) according to ICH-GCP guidelines, per regulatory requirements and Galderma Standard Operating Procedures (SOPs) and/or project specific procedures.


Job Responsibilities

  • Maintain a high level of understanding of applicable safety reporting regulations (e.g., FDA and ICH guidance, GCP regulations, EU Directives, country specific requirements etc.)
  • Maintain an up-to-date central filing system of pertinent safety documents and submissions
  • Submit expedited and periodic safety reports to business partners, Competent Authorities and Ethics Committees as applicable according to Galderma SOPs and the project specific safety reporting plan including any country specific reporting requirements
  • Distribute final regulatory reports to Clinical Operations or designee for reporting to Investigators and/or local IRBs/ECs
  • Submit SUSARs electronically through ARGUS Gateway
  • Liaise with applicable departments at Galderma and/ or vendor or service provider to ensure timely submission of Expedited and Periodic reports to applicable Regulatory Authorities and Ethics Committees and ensure all submissions are tracking appropriately and filed in the project folder
  • Escalate issues identified in reporting and processing of SUSARs and SAEs to Galderma Vigilance systems administrator
  • Provide input and review of responses to regulatory agency questions regarding Galderma compliance and to safety reporting requirements and tracking
  • Maintain awareness of reporting timelines for aggregate safety reports
  • Track regulatory submissions in the safety database or project specific tracking tool, as applicable
  • Assist in conducting root cause analysis for any late regulatory reports, audits, and inspections as required
  • Perform vendor compliance reconciliation as required per project
  • Assist in the development, maintenance, and update of Standard Operating Procedures (SOPs) and/or Working Instructions (WIs) or other guidance documents related to safety reporting, including those that are study specific

Minimum Requirements
  • Graduate degree in Life Sciences or nursing, or equivalent
  • A minimum of 3 to 4 years of global pharmacovigilance experience with at least 2 years of relevant experience in regulatory authority submission of clinical study ICSRs
  • Excellent knowledge of the clinical research process and current GCP/ICH guidelines applicable to conduct of clinical research
  • Excellent knowledge of safety databases and electronic reporting systems (Argus)
  • Excellent organization skills and ability to handle multiple priorities while adhering to applicable timelines
  • Positive attitude and ability to interact with all levels of staff to successfully coordinate and execute safety reporting activities
  • Flexibility to take on additional assignments as required and as the role develops
  • Eagerness to learn and to share knowledge with team members both internal and external to the company
  • Strong set of problem-solving skills, utilizing creative thinking to make informed decisions using thoughtful analysis
  • Ability to prioritize time effectively based on project needs
  • Ability to understand, evaluate and follow regulatory legislation and guidelines
  • Ability to work independently, follow instructions/guidelines and demonstrate initiative
  • Fluency in English, excellent written and verbal communication, and presentation skills
  • Computer literacy and experience working with Microsoft Office (Word, Excel, Teams, Outlook and PowerPoint)

Job Reference: 110000141
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締切: 04-05-2024

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