Director, Global Medical Safety

vor 4 Monaten

Zug, Schweiz Kiniksa Pharmaceuticals Vollzeit

Reporting to the VP, Global Medical Safety (GMS), the Director, Global Medical Safety will be responsible for working collaboratively to assess, track and document the ongoing benefit-risk profile of all products in development and marketing products. This includes contributing the safety sections of numerous aggregate reports (e.g., DSUR, PBRER, ASR), coordinating cross functional Safety Review Team (SRT) meetings, contributing to signal detection activities, and clinical development and product registration activities.

This role is based in our Zug office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.

**Responsibilities **_(including, but not limited to):_**
- Interact across multiple functions and support senior levels of the organization
- 30%-Safety Review Team meetings, and Signal Detection Activities:

- Oversee the technical and scientific support for safety surveillance and signal detection activities for assigned products via established signal detection methodology and tools. Evaluate signals promptly in signal detection reports and ad-hoc responses to regulatory authorities.
- Efficiently plan Internal Safety Review Committee and Safety Review Team (SRT) meetings, ensuring that stakeholders provide input from their respective areas of responsibility.
- Contribute to safety sections of Risk Management Plans (RMPs), if needed.
- 30%-Support for investigational products and registration activities:

- Effectively collaborate with stakeholders outside of GMS. Represent GMS department in cross-functional clinical programs and registrational activities and provide GMS support for clinical developmental programs.
- 20%- Aggregate report production:

- Oversee coordination and contribution to the production of periodic and ad-hoc safety reporting for therapeutic team products. Create safety content and coordinates, with Regulatory Affairs and Medical Writing, the completion of aggregate reports (e.g. PBRER, DSUR, PADER, as well as ad hoc queries or reports) for submission to regulatory agencies around the world. Collaborates with the Vice President or Designee to ensure that all information is available to allow for informed medical review and benefit-risk assessment. Responsible for the quality of the safety sections of relevant final document and providing an overall review.
- 20%-Support clinical development products in early stage (P1 and P2):

- Work with clin development stakeholders to develop early stage trial design
- Good understanding of drug pharmacology strongly preferred.
- May act as a manager for a product or group of products. Oversee and assume responsibility for assigned therapeutic products and PV activities through the lifecycle of the product. May include review of compliance in PV function and/or working directly with Kiniksa compliance staff.

**Qualifications**:

- 8-10 years pharmacovigilance experience
- MD/ MBBS or US/international equivalent required
- Understanding of the clinical development and relevant regulatory process
- Practical experience in the interpretation of global Pharmacovigilance regulations and implementation within an industry setting preferred. Alternatively demonstrate interchangeable skillset in healthcare related field
- Competence in conducting safety data reviews for investigational and/or post marketed products or equivalent experience in healthcare or research setting.
- Ability to contribute to and review standard operating procedures and other process-related documents
- Must be fluent in English with excellent written (scientific and non-technical) communication skills
- Ability to influence others within a matrix environment
- Ability to work in a fast paced-environment and to handle multiple tasks
- Strong commitment to compliance and ethical standards
- Ability to work independently, take initiative and complete tasks to deadlines
- Forward planning and proactive
- Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
- Support global decision-making and direction setting, including devising of future strategy and the management of complex tasks
- Salary is commensurate with experience

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