Executive Director, Drug Safety
vor 3 Monaten
**The Position**
- Strategic leadership role accountable for setting and implementing the overall safety strategy and procedures for an assigned therapeutic area product portfolio (medicinal products and/or medical devices), for post-marketing pharmacovigilance (PV) activities (including interventional and non-interventional studies) from a scientific perspective and safeguarding patient safety.
- Leading all interactions regarding product safety issues with Organon governance committees and regulatory agencies e.g., by active participation and contribution to amongst others the Organon Asset teams, Risk Management Safety Teams (RMSTs), Safety Review Committee (SRC), LEAD/LAST, NORSAP and other safety related decision-making governance bodies.
- Build strong relationships with the cross functional teams, to influence and ensure that the development-, regulatory and or medical strategy and procedures are aligned with the safety strategy as well as with company objectives.
- Ensure that the scientific safety assessment of assigned products is driven by comprehensive and customer-focused strategic patient safety expertise, for effective benefit-risk decision-making by guidance, expertise sharing, coaching and/or training of the Drug Safety Leads, Safety scientists leads and Safety Scientists.
- Business process ownership of assigned core safety science processes and liaison between the different GPSS teams for PV system implementation and maintenance as well as issue resolution
- Line-Management, development of staff in the Safety Science Therapeutic Areas at the Global Pharmacovigilance and Safety Science (GPSS) Department.
Organizational Relationships
- Reporting to the Associate Vice President, Safety Science Lead, GPSS
**Responsibilities**
- Responsible for leading and driving safety strategy for the development and maintenance of assigned products.
- Ensures the scientific foundation of the Benefit-Risk profile of Organon products, risk communication, inclusion of complete safety information in company core safety documents as well as the compliance of company drug safety.
- Fulfill a leadership role in Benefit-Risk Balance related decision-making boards and/or committees, teams (e.g., RMST, RDRC, SRC, NORSAP) and provide strategic input.
- Establish strong relationships with important stakeholders in the Company in relation to B/R balance discussions and management.
- Will collaborate with appropriate cross-functional Organon departments (respectively partner companies) to ensure efforts are aligned to meet global risk management strategies for the product portfolio.
- Responsible for leading all interactions regarding product safety issues with Organon governance committees and regulatory agencies.
- GPSS
- Works closely with GPSS Leadership to implement the evolving direction for the risk management and safety function of the department, as well as helping to develop and align processes to support departmental objectives.
- Will lead and manage a team of safety physicians and - scientists and has an oversight role for their products (if applicable also remote).
- Supporting Drug Safety Training for Organon staff (initial, refresher and continuous) and communication to ensure PV awareness and understanding.
- Ensuring ICH/FDA/EMA guideline compliance of company drug safety, monitor compliance and demonstrate compliance in audits.
- Liaise with other sections in GPSS (e.g., QPPV office, PV OPS, GQC, PV affiliate, SS BD) to streamline processes ensuring timely and high-quality data management, processing and output.
- Provide scientific expertise to organization in particular to interdisciplinary developmental teams as well as post-marketing teams.
- Health Authority interaction:
- Manage the timely authoring of high-quality aggregate safety reports (ASR), response to questions (RTQ) and other scientific reports.
- Ensuring proper scientific reflection of the B/R balance in periodic safety update reports as well as Risk Management Planning.
- Measuring effectiveness of additional risk minimization activities.
- Active role in preparing expert reports as appropriate and preparing safety regulatory files e.g., health authority responses.
- Represent GPSS and safety topics in Health Authority meetings (e.g., scientific advice).
- Act as key-SME during inspections.
- Act as point of contact for safety related topics with partners and/or vendors (e.g., ASR vendor, signaling vendor).
- Ensures appropriate oversight of SS process related vendor activities.
- Providing expert input on and ensuring safety tasks in clinical trials (including protocol review, SUSAR, ASR/DSUR, safety reporting, informed consent forms, investigator brochure, unblinding) are handled appropriately and in compliance with regulations as well the design of the study meets the needs for risk management and B/R balance activities.
- Ensure continuous safety profile monitoring by means of Signal detection and benefit/risk evaluations inclu
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