Senior benefits risk management lead

Overview

As the Senior PV Benefit‑Risk Management Lead/Oncology you will operate in a highly senior, strategic leadership role within Pharmacovigilance, providing enterprise‑level oversight of benefit‑risk management activities. You will lead and provide strategic direction to Global Safety Leaders (GSLs), working in close collaboration with cross‑functional product teams and PV BRM experts to drive consistent, high‑quality benefit‑risk strategy and decision‑making across the portfolio. With substantial experience across early clinical development and strong understanding of benefit‑risk considerations from First‑in‑Human through early Phase trials, you will be accountable for ensuring patient safety throughout the full product lifecycle from pre‑clinical development through post‑marketing by providing strategic oversight of benefit‑risk assessment and risk minimization activities.

Key Working Relations

• Leadership level interface with Global Project Management, Drug Development, Clinical Sciences, Clinical Development, Medical Affairs, Regulatory Affairs and Business Development.
• Direct presentations or oversight of presentations to governance committees such as GSC, GLC and other senior management committees.
• Representation where needed with health authorities and external scientific bodies.

Responsibilities

• Leading product groups responsible for ongoing BRM and/or leading BRM activities for products of strategic importance by providing in‑depth assessment of complex safety and benefit‑risk topics based on an in‑depth knowledge of oncology clinical development, evidence‑based medicine, key pharmacovigilance topics (e.g. DILI), quantitative signal detection and the wide range of ways to assess, communicate and manage the benefit‑risk balance.
• Responsible for the effective performance for the product/product group of clinical signal detection, evaluation and benefit risk management including:
• Monitoring and managing the benefit‑risk profile of assigned product/product group in an ongoing fashion by leading cross‑functional Safety Management and Benefit‑Risk Management teams and implementation of state‑of‑the‑art strategies to proactively monitor and assess the benefit‑risk balance.
• Identifying, prioritising and analysing clinical safety signals.
• Leading the patient benefit‑risk management processes through Safety Management Teams.
• Ensuring appropriate clinical safety risk communication and escalation within Bayer Pharma to PV Management and QPPV and committees including SRC, GSC, PET and GLC.
• Producing high quality aggregate reports and responses to regulatory queries.
• Ensuring adequate labeling of safety‑related information.
• Ensuring effective due diligence activities. Working with the Systems and Operations teams to develop and continuously maintain and improve effective systems to ensure single cases (incl. PTCs and other relevant reports) are of submission quality and fulfil the requirements for signal detection and aggregate report compilation.
• Providing the strategic leadership for the product/product group and high quality and consistent input to development teams and product teams to support clinical development and life‑cycle management.
• Planning and deploying skilled resources against project priorities.
• Contributing to development of budget and working within those allocated constraints throughout the fiscal cycle.
• On‑boarding, training and development within the product/product group.
• Maintaining an environment of continuous improvement within the team and contributing to continuous improvement initiatives across PV.

Strategic Goals of PV

• Support the PV Leadership Team in strategic decision making.
• Support and lead process improvement and implementation across BPH.
• Work collaboratively to ensure consistency of approach across Therapeutic Groups.
• Maintain effective business relationships to other Bayer Pharma functions to support the implementation of BPH clinical safety standards.

Qualifications

• MD degree or equivalent (eg, DO or MB).
• 10+ years in the Pharmaceutical, Life Sciences or Healthcare industry.
• 5+ years of pharmacovigilance experience with focus on oncology throughout the product lifecycle (pre‑clinical to Phase 4 and post‑marketing).
• Significant experience in conducting routine safety surveillance throughout the product life cycle, signal monitoring and detection, development of aggregate safety reports; preparation of submission related documents, including 2.7.4 and 2.5, RMPs, CCDS/labels and safety‑related regulatory interactions; responses to regulatory queries; assessment of the overall benefit‑risk profile throughout the product lifecycle.
• Strong experience and direct interactions with Major Regulatory agencies.
• Ability to interact with expert consultants and Key Opinion Leaders.
• Knowledge of relevant concepts in oncology drug development, epidemiology, statistics and evidence‑based medicine.
• Proven history of effective leadership within a matrix organization.
• Experience with the PV toolbox regarding databases/other IT/Coding systems etc.

Competencies

• Excellent knowledge of pharmacovigilance relevant regulations and proven evidence of effective delivery of high‑quality safety relevant documents.
• Knowledge of relevant concepts in data management and systems, pharmacoepidemiology and statistics.
• Effective communicator and ability to communicate complex issues in an understandable, effective and relevant manner.
• Effective in written and spoken English.
• Strong influencing skills with the ability to explain and defend a position in the face of opposition.
• Effective team member. Takes ownership of appropriate issues and appropriately delegates.
• Team oriented, recognising the value of and utilising diversity.
• Strategic focus to activities and planning, with proactive planning and prioritisation skills.
• Effectively applies processes across assigned team.
• Technical expertise in pharmacovigilance and clinical safety.
• Excellent analytical and problem‑solving skills.
• Provide effective and relevant review of complex documents.
• Knowledge of relevant legislations and guidelines.

Benefits & Compensation

• Salary between £110K - £130K pa depending on experience. Salary reviews take place annually in April.
• Annual company bonus.
• Individual bonus can also be granted for top Talent Impact.
• Long Term Incentive Bonus.
• Car Benefit.
• 28 days annual leave, plus bank holidays and volunteering days.
• Private Healthcare.
• Pension scheme.
• Life Insurance.
• Wellness programmes and support.
• Employee discount scheme.
• Flexible and Hybrid working.
• Support with home office equipment.
• Support for professional growth in a wide range of learning and development opportunities.