Scientific Associate Vice President, Drug Safety
Vor 2 Tagen
**The Position**
- Effective leadership of the Safety Science (SS) team and effective cross
- functional collaboration and engagement with Organon's business strategy and goals.
- Controlled fulfillment of all legal obligations and company duty-of-care requirements relative to drug and device safety relating to SS activities.
- Ensure that SS delivers comprehensive and customer-focused strategic patient safety expertise to clinical development, marketed products, onboarding of in
- licensing opportunities, for effective benefit-risk decision-making and timely delivery of right-quality documents.
- State of the art medical evaluation of all adverse event reports from different sources (spontaneous, clinical trial, literature and others), Benefit-Risk Balance assessment and risk minimization activities.
- Standard Operating Procedures governing activities of SS are up
- to-date and compliant with legislation.
**Responsibilities**
- Effective safety decision-making throughout the life-cycles of all our Company's medicinal products (and medical devices).
- Direct safety science staff, to ensure that the company meets its objectives and legal obligations with respect to pharmacovigilance (PV).
- Oversight and coaching of Risk Management Safety Teams (RMST) and monitoring the output (safety strategy, documentation).
- Champion robust safety signal and risk management processes with comprehensive product safety surveillance, prompt management of any safety issues, and ongoing patient risk management, e.g.:
- Proactive signal detection, evaluation and management together with the EU Qualified Person for Pharmacovigilance (QPPV).
- State of the art benefit-risk analyses.
- High quality and scientifically accurate aggregate safety reports in collaboration PV Operations and with other relevant departments (PSUR, DSUR, RMP etc.).
- Collaborate effectively with the Associate Vice Presidents Clinical Development, Medical affairs and outcomes research, Non-Clinical Drug Safety and other functions to guarantee an integrated scientific approach to the safety of all our Company's products, during research and development, and after marketing authorization (or CE Mark) approval, in order to meet international regulatory requirements, achieve company objectives, and secure patient safety.
- As voting member of the Organon Safety Review Committee (SRC), Technical Review Committee (TRC) and member of other relevant decision-making governance committees, impart senior safety expertise to benefit-risk and project milestone decisions for all our Company's products.
- Support Clinical Development/Regulatory Affairs/Affiliates on ad hoc questions concerning medical/clinical safety (expert reports, regulatory dossiers).
- Escalating drug safety issues for further investigations in a timely manner to CSO, CMO or other relevant senior management stakeholders.
- Ensuring ICH/FDA/EMA guideline compliance by;
- Setting up adequate SS process oversight by means of metrics reports and KPI monitoring.
- Ensure creation and reinforcing of medical / clinical safety related SOPs, processes and IT systems.
- Responsible for building and managing a well-functioning Safety Science team including outsourced resources and continuous development of competencies, knowhow and skills.
- Special duties on assignment.
Tasks
- Ensure business process ownership of SS core processing including but not limited to; medical review, (ad hoc) scientific literature searches, aggregate safety reports, signal management, Risk Management Safety Team process, risk management planning and risk minimization activities, Benefit-Risk balance assessment, core safety labeling.
- Initiating appropriate measures e.g., preparing /reviewing Safety Review Committee presentations, change control of SmPC/CCDS, updating risk management plan and resulting actions plans.
- Supporting Regulatory department with evaluation of adverse event profile of product to update regulatory documents, support in answering safety related health authority enquiries in particular emerging safety issue and external safety communication.
- Leading expert during inspections and ensuring timely creation and submission of SS related corrective and preventive action (CAPA) response document.
- Oversight of SS related deviations and/or quality issues and timely CAPA resolution.
- Manage and lead the Safety Science Team including performance review, operational management, current and future resources.
- Supports/conducts safety trainings for new staff, pharmacovigilance staff as well as refreshers.
- Ensures safety tasks in clinical trials (including protocol review, SUSAR, safety reporting, informed consent forms) are handled appropriately and in compliance with regulations.
- Active involvement in PASS or other safety studies.
- Ensures timely safety surveillance - and benefit-risk communication with local PV responsible persons is shared and interfaces between local and SS are clear and trained.
- Key
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