Risk Management Director
- Experience Level
- Experienced (non-manager)
I am seeking an experienced Risk Management Physician (RMP) to join a leading global pharma company in Germany and work on various products in clinical development or post-marketing drug safety.
In this role as a ‘Senior RMP’, you lead the global Pharmacovigilance (PV) and Risk Management (RM) activities for compounds in clinical development or in the market.
Tasks & Responsibilities
- Develop proactive patient-centric RM strategies for assigned compounds
- Plan, manage and monitor all PV activities for assigned drugs, including:
- Set-up of safety analyses in the clinical trial and safety databases for Monitoring
- Continuous monitoring and further development of the product safety profile
- Safety issue management
- Collaboration with Global Epidemiology and Medical Affairs on safety-focused clinical and epidemiologic studies
- Collaborate with various departments including clinical development to develop safety profile assessment strategies for developmental products.
- Provide interpretation of clinical trial safety data for clinical trial reports and submission documents. Be responsible for the drug safety related regulatory documents (e.g. PSURs, DSURs, RMPs, Clinical Overview Statements)
- Chair or be part of an internal multidisciplinary PV working group and represent Global PV in internal and external committees & bodies
- Medical doctor with clinical or research experience (diabetes/metabolism, cardiovascular or renal therapeutic areas would be an asset)
- Several years of PV experience and good understanding of PV regulation in major markets
- Experience in Clinical Development (submissions for marketing authorization would be an asset)
- Clinical or research experience in diabetes/metabolism, cardiovascular or renal therapeutic areas would be an asset
- Good interpersonal and communication skills
- Competitive basic salary
- Great growth/ Progression
- Industry leading company
- Generous vacation time
- numerous benefits towards your wellness & financial health and work-life balance
For more information, contact Antonia at Barrington James.
Recruitment Resourcer Medical Affairs & Clinical Development
adavis (@) barringtonjames.com
+44 1293 776644
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