Senior Associate Director Safety - CVRM

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

Requirements

• 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

Benefits

• Competitive basic salary
• Bonus
• 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 
Antonia Davis 

adavis (@) barringtonjames.com
+44 1293 776644