about 1 month ago
Hamlyn Williams is working with a global innovative biopharmaceutical company that has it’s European Headquarters based in Munich. The company is currently looking for a PV Director to cover the oncology or cardiology franchise for Europe, collaborating closely with counterparts in the US & Asia.
· Lead the European safety team for the selected franchise
· Engage with global product teams to manage safety profiles
· Provide strategic guidance for preparation of safety relevant parts of submission documents for marketed products as requested by European authorities
· Management of Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs) and Signal Detection Reports
· Support EU Lead for PV evaluation for CV products and creation of response documents for health authority requests
· Medical-scientific analysis of clinical trials, Post Authorisation Safety Studies (PASS) and non-interventional studies (NIS) concerning pharmacovigilance aspects
· Performs pharmacovigilance activities as a function of European Headquarters including Medicinal Case Assessment for marketed and investigational drugs
· Ensures compliance with all legal requirements with respect to Pharmacovigilance in Germany, initiates and controls continuous adaptation to new legal requirements
· Supports global pharmacovigilance activities such as global working groups, e.g. GWT Medical as needed
This is a permanent role, offering a generous pay package for the right person. You need to be an experienced Safety Physician who has experience of working at an international level.
If this role is of interest or you have any questions, don’t hesitate to get in touch.