Global Safety Leader
Your tasks and responsibilities
Responsible for the safety assessment activities of assigned products under the supervision of Global PVRM Therapeutic Area Head, including:
• Monitor the benefit risk profile of assigned portfolio in an ongoing fashion and in accordance with BPH and GPV processes
o Lead the PV risk management processes including chairing Safety Management Teams
o Identify, prioritize and analyze clinical safety signals
o Perform ongoing review of emerging safety data from various sources including single case reports, PTCs and published literature and reports from partner functions
o Work with the Systems and Operations teams to develop and continuously maintain and improve effective systems to ensure single cases (inc PTCs and other relevant reports) fulfill the requirements for signal detection and aggregate report compilation through targeted training
o Ensure appropriate clinical safety risk communication and escalation within BPH to GPV Management and QPPV and BPH Safety Committees including SRC, GSC, PET and GLC
o Produce high quality aggregate reports and responses to regulatory queries
o Ensure adequate labeling of safety related information
• Ensure effective and timely delivery of:
o Aggregate reports including PSUR/PBRERs, DSURs, DRMPs and RMPs (core and EU)
o Benefit Risk Statements
o Safety section of DCSI and relevant Position paper and Justification documents
o Answers to assigned safety relevant HAs requests and complex A2Qs
o Safety relevant communications such as DHCP letters and company statements.
• Liaise with internal and external experts /KOLs to obtain specialized medical expertise as appropriate
• Provide high quality and consistent input to development teams and product teams to support clinical development and life cycle management
• 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
• Perform effective due diligence activities within the assigned TA
• Support GPV-RM TA Head in strategic decision making
Minimum/Required Education and Experience
• MD degree or equivalent (eg, DO or MB) required.
• Two years or more of clinical experience as well as at least 2 years of pharmacovigilance experience, or overall equivalent experience profile.
• Specialty certification preferred.
• Appropriate experience with Regulatory Agency and KOL interactions
• Good knowledge of pharmacovigilance relevant regulations and BPH standards.
• Proven evidence of effective delivery of high quality safety relevant documents.
• Knowledge of relevant concepts in data management and systems pharmacoepidemiology and statistics
• Fluent English