Job Description
* As a Strategic Safety Lead, you will be responsible for setting and implementing the overall safety strategy and procedures for an assigned therapeutic area product portfolio. This includes post-marketing pharmacovigilance activities from a scientific perspective, ensuring patient safety and safeguarding the company's interests.
* You will lead all interactions regarding product safety issues with Organon governance committees and regulatory agencies, actively participating in decision-making bodies such as the Risk Management Safety Teams (RMSTs), Safety Review Committee (SRC), LEAD/LAST, NORSAP, and others.
* You will build strong relationships with cross-functional teams to ensure that development, regulatory, and medical strategies are aligned with the safety strategy and company objectives.
* You will drive the scientific safety assessment of assigned products, leveraging comprehensive and customer-focused strategic patient safety expertise to inform benefit-risk decision-making.
* You will oversee business processes related to core safety science and liaison between Global Pharmacovigilance and Safety Science (GPSS) teams for PV system implementation and maintenance, as well as issue resolution.
* You will manage a team of safety physicians and scientists, overseeing their work and providing guidance on safety-related matters.
Key Responsibilities
* Lead and drive safety strategy for development and maintenance of assigned products.
o Evaluate and establish the scientific foundation of the Benefit-Risk profile of Organon products.
o Communicate risk information effectively and ensure complete safety information is included in company core safety documents.
* Collaborate with cross-functional departments to align efforts and meet global risk management strategies for the product portfolio.
* Represent GPSS and safety topics in Health Authority meetings and act as a key SME during inspections.
* Ensure compliance with regulations, including ICH/FDA/EMA guidelines, and demonstrate compliance in audits.
* Liaise with other sections in GPSS to streamline processes and ensure timely data management, processing, and output.
* Provide scientific expertise to interdisciplinary developmental teams and post-marketing teams.
* Manage aggregate safety reports, responses to questions, and other scientific reports.
* Evaluate the Benefit-Risk balance in periodic safety update reports and Risk Management Planning.
* Measure the effectiveness of additional risk minimization activities.
* Act as a point of contact for safety-related topics with partners and/or vendors.
Requirements
* Medical degree, ideally with clinical experience in woman's health, internal medicine, cardiology, neuroscience, or equivalent.
* 10+ years of experience in the pharmaceutical industry, with 5-10+ years in drug safety and pharmacovigilance.
* Extensive knowledge of PV deliverables, standards, and processes at a global level.
* Experience in Pharmacoepidemiology, Benefit-Risk profile process implementation, data analysis, signal management, and benefit/risk monitoring.
* Comprehensive knowledge of pharmacovigilance and clinical trial legislations globally.
* Excellent verbal and written communication skills, analytical skills, and demonstrated leadership skills.
Preferred Qualifications
* Board certification.