Medical Safety Leader New
il y a 6 jours
Location:
Mechelen
- Contact:
Amandine Planche
- Job type:
Permanent
- Contact phone:
+32 10 68 53 34
- Industry:
Pharmaceutical, Life Sciences, Clinical Research, Transportation
As a Medical Safety Leader, you are responsible for global pharmacovigilance activity of dedicated investigational products portfolio, including review and analysis of safety data from non-clinical and clinical trials, quality control of ICSRs, identification and management of safety signals, management of benefit-risk profile of the assigned compounds, scientific review of internal and external documents.
**Responsibilities**
- Ensure that all operational processes, regarding pharmacovigilance, are followed in assigned project
- Manage the external service providers delivering pharmacovigilance services, up to industry standards as per regulations and guidelines, including financial follow up, quality control of the ICSRs, PSURs and any other Safety related documents, compliance with regulatory requirements (timely submission of expedited and periodic reports)
- Perform medical review and provide medical advice on safety-related aspects associated with the assigned compounds
- Chair regular meetings of the Safety Management Teams overseeing the compound Safety profile
- Review and validate ICSRs from ongoing clinical studies and collaborate with the External service provider to process the ICSR, ensure expedited reporting requirements are met
- Review of a study-specific Safety Project Plan for assigned clinical studies across the portfolio, and ensure oversight on the activities executed accordingly
- Integrate the safety scientific component to build up a strategic framework for clinical development plans
- Contribute to the creation and review of the Safety parts of certain clinical study related documents - Clinical Study Synopsys/Protocols, Clinical Study Report
- Contribute to the creation and review of the Safety parts of certain compound related documents - Investigator's Brochure, dRMP,
- Initiate, author, oversight and collaborate with the Regulatory Leader to create and submit the Development Safety Update Report (DSURs)
**Requirements**:
- MD degree or equivalent (eg, DO or MB) required
- 7 years or more of clinical experience and/or Industry experience, with at least 3 years of these in patient safety or pharmacovigilance
- Previous experience in phase 1 to 3 clinical trials strongly preferred
- Prior Oncology experience strongly preferred, either in clinical practice or drug safety
- Immunology experience would also be beneficial plus
- Experience with interactions with major Regulatory Agency is preferred
- Effective team member who takes ownership
- Demonstrated attention to detail, strategic thinking and problem solving skills
- Able to work under stress, demonstrating initiative and flexibility
- Existing right to work in Europe is required
**Benefits**
- Fulltime position
- Remote
- A balanced salary package based on your capabilities and experience, including extra legal benefits
Vacancy number: 24460
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