Global Safety Leader

Responsible for the safety assessment activities of assigned products under the supervision of Global PV BRM Therapeutic Area Head for Cell and Gene Therapy & Rare Diseases, including:

• Monitor the benefit risk profile of assigned portfolio in an ongoing fashion and in accordance with Bayer's 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, product technical complaints 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 (including 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 Bayer to PV Management and QPPV and Bayer 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:
• Aggregate reports including PSUR/PBRERs, DSURs, DRMPs and RMPs (core-and EU-RMP)
• Benefit Risk Statements
• Safety section of IB and relevant position papers and justification documents
• Answers to assigned safety relevant HAs requests and complex A2Qs
• 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-BRM TA Head
• Support GPV-RM TA Head in strategic decision making
  
  MD degree or equivalent (eg, DO or MB) required, with clinical practice experience
• Good clinical practice experience and/ or Industry experience, with a focus on patient safety or prior pharmacovigilance experience preferred.
• Deep knowledge of the specific therapeutic area, including immunology, transplant medicine, internal medicine, hematology is strongly preferred.
• Experience with interactions with major Regulatory Agency is preferred.
• Ability to interact with Key Opinion Leaders.
• Good knowledge of pharmacovigilance relevant regulations.
• Proven evidence of effective delivery of high quality safety relevant documents.
• Knowledge of relevant concepts in epidemiology and statistics.
• Effectively communicates in written and spoken English.
• Communicates complex issues in an understandable, effective and relevant manner.
• Strong influencing skills with the ability to explain and defend a position in the face of opposition.
• Strategic focus to activities and planning, with proactive planning and prioritization skills.
• Effective team member.
  
  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.
  
  Be You at Bayer where you have the opportunity to be part of a culture influencing Health for all and Hunger for none.
To achieve our vision we see reward for all our employees as incredibly important, so here are some of the benefits you will receive as a Bayer employee. What we offer
• Competitive compensation package consisting of an attractive base salary and annual bonus. Individual bonus can also be granted for top performance awards.
• 28 days annual leave plus bank holidays
• Private Healthcare, generous pension scheme and Life Insurance
• Wellness programs and support
• Employee discount scheme
• State of the art offices
• International career possibilities
• Flexible and and Hybrid working
• Help with home office equipment
• Volunteering days
• Support for professional growth in a wide range of learning and development opportunities
• We welcome and embrace diversity providing an inclusive working environment