My client a leading global pharmaceutical company in the innovation & commercialization in Cardiovascular Medicines, with a global HQ in Germany, is currently looking for a Global Safety Physician Director to lead PV activities for development products.
• Responsible for the safety assessment activities of assigned products and monitor the benefit risk profile of assigned portfolio in an ongoing fashion
• Lead the pharmacovigilance (PV) benefit risk management processes and the safety management
• Continuous review of emerging safety data from sources including single case reports, published literature and reports from partner functions
• Identify, prioritize and analyze clinical safety signals and perform ongoing review of emerging safety data from various sources
• Collaboration with the system and operation teams to develop and continuously maintain and improve effective systems to ensure single cases, fulfill the requirements for signal detection and aggregate report compilation through targeted training
• Produce high quality aggregate reports and response to regulatory queries as well as ensure adequate labeling of safety related information
• Responsible for delivery of benefit risk statements and safety section of Reference Safety Information and relevant position paper and justification documents
• Provide relevant communications such as drug safety communications (DHCP letters) and company statements
• Liaise with internal and external experts/key opinion leaders (KOLs) to obtain specialized medical expertise
• Provide medical safety oversight of clinical study data in the context of the medical review process for clinical studies
• Interact with license partners to support the global license officer in the preparation and maintenance of PV agreements
• Medical degree or equivalent
• Several years of clinical (preferably internal medicine, cardiovascular or thrombosis) and PV experience
• Appropriate experience with regulatory agencies and KOL interactions
• Good knowledge of pharmacovigilance relevant regulation and proven evidence of effective delivery of high quality safety relevant documents
• Knowledge of relevant concepts in data management and systems, pharmacoepidemiology and statistics
• Technical expertise in pharmacovigilance and clinical safety • Strategic focus with proactive planning and prioritization skills
• Ability to inspire and motivate co-workers as well as build partnerships and work collaboratively with others to meet shared objectives
• Excellent analytical skills and high ability to solve problems and to structure and simplify complex tasks
• Fluent in English, both written and spoken
Interested to find out more??? Feel free to contact me, Samuel Whyley-Smith for a friendly and discreet chat about this career opportunity on 0044 (0)114 2945 008 or via email on firstname.lastname@example.org
If you feel this role is right for you then hit... APPLY NOW!!!
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