Global Safety Leader MD

 

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

 

Global Safety Leader MD 

 

 

 

The Global Safety Leader will provide medical safety expertise, state of the art pharmacovigilance, and safety risk management for an assigned portfolio of products (both marketed and in development).The Global Safety Leader ensures patient safety of Bayer Healthcare products and maintenance of compliance with the Pharmacovigilance regulations of Regulatory Agencies around the globe through the effective and timely completion of GPV Assessment activities through product development, product maintenance and life cycle management.

 

YOUR TASKS AND RESPONSIBILITIES

 

 

The primary responsibilities of this role, Global Safety Leader, are to:

 

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 BSP and GPV processes;
• Lead the PV risk management processes including chairing Safety Management Teams;
• Identify, prioritize and analyze clinical safety signals;
• Perform ongoing review of emerging safety data from various sources including single case reports, PTCs and published literature and reports from partner functions;
• 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;
• Ensure appropriate clinical safety risk communication and escalation within BSP to GPV Management and QPPV and BSP Safety Committees including SRC, GSC, PET and GLC;
• Produce high quality aggregate reports and responses to regulatory queries;
• 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);
• 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;
• Plan and deploy skilled resources against project priorities in consultation with GPV-RM TA Head;
• Support GPV-RM TA Head in strategic decision making.

 

 

WHO YOU ARE

 

 

Bayer seeks an incumbent who possesses the following:

 

 

Required Qualifications:

 

• MD degree or equivalent (eg, DO or MBBS) is required;
• Robust Clinical and Pharmacovigilance experience is required;
• Appropriate experience with Regulatory Agency and KOL interactions.;
• Good knowledge of pharmacovigilance relevant regulations and BHC standards;
• Proven evidence of effective delivery of high quality safety relevant documents;
• Knowledge of relevant concepts in data management and systems , pharmacoepidemiolog