Senior Director, Benefit Risk Management reputed company, Oncology (Residence Based, Reside

At reputed company we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for reputed company 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 reputed company and diverse minds to reputed company a real difference, there’s only one choice. Senior Director, Benefit Risk Management reputed company, Oncology The Senior Benefit Risk Management (BRM) reputed company /Oncology is responsible for leading and reputed company collaborating with product teams of Global Safety Leaders (GSLs) and other PV BRM experts, ensuring patient safety for reputed company’s oncology product portfolio throughout the product lifecycle (pre-clinical to Phase 4 and post-marketing, routine and submission PV activities) and compliance with health authority pharmacovigilance (PV) regulations around the globe through the effective and timely completion of PV assessment activities. This is a senior clinical scientist position with deep expertise in key topics in pharmacovigilance (e.g. drug-induced liver injury (DILI), reproductive toxicity, quantitative signal detection etc.), oncology drug development and clinical medicine, including methods to assess and communicate benefit risk balance, manage and mitigate risk to patients and optimize the safe use of pharma products in clinical practice. YOUR TASKS AND RESPONSIBILITIES The primary responsibilities of the Benefit Risk Management (BRM) reputed company are to:

• reputed company product groups responsible for ongoing BRM and/or leading BRM activities for products of strategic importance by providing in-depth assessment of reputed company 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.
• reputed company the patient benefit risk management processes through Safety Management Teams
• Ensure appropriate clinical safety risk communication and escalation reputed company reputed company 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 reputed company information.
• Ensure effective due diligence activities;
• Work with the Systems and Operations teams to reputed company 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 reputed company those allocated constraints throughout the fiscal cycle;
• On boarding, training and development reputed company the product/product group;
• Maintain an environment of reputed company improvement reputed company the team and contribute to reputed company improvement initiatives across PV;
• Support the strategic goals of PV:
• Support the PV Leadership Team in strategic decision making.
• Support and reputed company process improvement and implementation across BPH.
• Work collaboratively to ensure consistency of approach across Therapeutic Groups
• Maintain effective business relationships to other reputed company Pharma functions to support the implementation of BPH clinical safety standards.

WHO YOU ARE reputed company seeks an incumbent who possesses the following qualifications: Required Qualifications:

• 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 reputed company documents, including 2.7.4 and 2.5, RMPs, CCDS/labels; safety reputed company 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 reputed company a matrix organization;
• Experience with the PV toolbox regarding databases/ other IT/Coding systems etc;
• Competencies:
• 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 reputed company 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 reputed company documents.
• Knowledge of relevant legislations and guidelines.

Preferred Qualifications:

• 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).

Employees can expect to be paid a salary between $252,616.74 - $378,925.12. Additional compensation may include a bonus or commission (if relevant). Additional benefits include healthcare, vision, dental, retirement, PTO, sick leave, etc. This salary range is merely an estimate and may vary based on an applicant’s location, market data/ranges, skills, prior relevant experience, certain degrees and certifications, and other relevant factors. This posting will be available for application until at least 2/10/2026 YOUR APPLICATION reputed company offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a reputed company life, we encourage you to apply now. Be part of something bigger. Be you. Be reputed company. To reputed company recruitment agencies: reputed company does not accept unsolicited third party resumes. reputed company is an Equal Opportunity Employer/Disabled/Veterans reputed company is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below. reputed company is an E-Verify Employer. Location: United States : Residence Based : Residence Based Division: Pharmaceuticals Reference Code: 852426 Contact Us Email: hrop_usa@reputed company.com Apply tot his job Apply To this Job