What are the responsibilities and job description for the PV and Clinical Development Expert position at Kiniksa Pharmaceuticals?
We are looking for a highly skilled and experienced PV and Clinical Development Expert to join our team at Kiniksa Pharmaceuticals. As a key member of our Global Medical Safety organization, you will be responsible for leading and collaborating to assess, track, and document the ongoing benefit-risk profile of all marketed products and those in development.
The ideal candidate will have 10 years of experience in Safety/Pharmacovigilance, with a strong understanding of drug pharmacology and clinical development processes. They will be able to contribute to safety sections of aggregate reports, coordinate cross-functional Safety Review Team meetings, and ensure the completion of signal detection activities.
This role requires excellent communication, collaboration, and networking skills, as well as the ability to influence others within a matrix environment. The successful candidate will be able to work independently, take initiative, and complete tasks to deadlines while supporting senior levels of the organization.
Key responsibilities include:
- Managing multiple competing tasks and demands in a fast-paced environment
- Developing early-stage trial design for clinical development products
- Reviewing compliance in PV function and/or working directly with Kiniksa compliance staff
- Providing an overall review of safety sections of relevant final documents
