Bayer · 1 month ago
Senior Benefit Risk Management Lead, Oncology
United States
Full-time
Remote
Senior Level
$253K/yr - $379K/yr
5+ years expBayer is a company driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is a reality. They are seeking a Senior Benefit Risk Management Lead in Oncology responsible for ensuring patient safety for Bayer’s oncology product portfolio and compliance with pharmacovigilance regulations throughout the product lifecycle.
BiotechnologyChemicalHealth CareLife SciencePharmaceutical
Responsibilities
Lead 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:
Monitor and manage 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
Identify, prioritize and analyze clinical safety signals
Lead the patient benefit risk management processes through Safety Management Teams
Ensure appropriate clinical safety risk communication and escalation within Bayer Pharma to PV Management and QPPV and 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 due diligence activities
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) are of submission quality and fulfill the requirements for signal detection and aggregate report compilation
Provide the strategic leadership for the product/product group
Provide high quality and consistent input to development teams and product teams to support clinical development and life cycle management
Plan and deploy skilled resources against project priorities
Contribute to development of budget and work within those allocated constraints throughout the fiscal cycle
On boarding, training and development within the product/product group
Maintain an environment of continuous improvement within the team and contribute to continuous improvement initiatives across PV
Support the 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
Qualification
Required
MD degree or equivalent (eg, DO or MB)
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; 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
Excellent knowledge of pharmacovigilance relevant regulations. 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
Effectively communicate 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 orientated, recognizing the value of and utilizing diversity
Strategic focus to activities and planning, with proactive planning and prioritization 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
Preferred
Long term experience (:10 y) in the Pharmaceutical, Lifesciences or Healthcare industry with 5 or more years of pharmacovigilance experience with focus on oncology throughout the product lifecycle (pre-clinical to Phase 4 and post-marketing)
Benefits
Healthcare
Vision
Dental
Retirement
PTO
Sick leave
Company
Bayer
Bayer is a life science company that specializes in the areas of health care and agriculture.
10001+ employees
H1B Sponsorship
Bayer has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (62)
2024 (71)
2023 (76)
2022 (141)
2021 (138)
2020 (117)
Funding
Current Stage
Public CompanyTotal Funding
$9.34BKey Investors
Bank of AmericaBill & Melinda Gates FoundationTemasek Holdings
2025-09-26Post Ipo Debt· $331.5M
2024-12-06Post Ipo Debt· $5.29B
2022-11-08Grant· $12M
Leadership Team
Wolfgang Nickl
Member of the Board of Management of Bayer AG and CFO
Abi Abitorabi
VP, CGT Platform Implementation Lead
Recent News
2026-01-09
2026-01-09
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