Global Safety Lead

The Global Safety Lead (GSL) is a senior drug safety expert/physician who is responsible for / recognized as the go-to person for the safety strategy throughout the product lifecycle for assigned marketed / development product(s). The GSL will maintain current knowledge of the Menarini-Stemline (MS) product portfolio in addition to assigned products. The GSL will have accountability for safety surveillance, risk management, risk communication, medical assessment of individual adverse event reports, the generation and review of aggregate reports, risk management plans (including REMS) and other safety documents, including labelling changes. The Global Safety Lead will collaborate with the VP of Drug Safety & Pharmacovigilance/Head of Medical Safety to develop the strategic roadmap for managing the benefit risk profile of assigned product(s). The GSL will serve on relevant MS inter-departmental teams representing Drug Safety & Pharmacovigilance.

Please note--this position is classified as a corporate office position. In accordance with the New York employer convenience rule, Stemline will withhold New York state income taxes for all corporate office employees, regardless of whether these employees work in New York or remotely.

• Serves as a Global Safety Lead (GSL) and Menarini-Stemline (MS) patient safety expert/physician for assigned product(s) - Providing safety strategy and oversight for managing the risk-benefit profile of the products assigned, being responsible key role, sitting in the Compound /Asset Development Team, for the safety surveillance, risk communication and risk management of the product. This position is responsible for the proactive and timely risk-benefit assessments of safety data to characterize the emerging and known safety profiles of development and marketed company products
• Ensuring the submission of aggregate reports (e.g. PBRER, PADER, PSURs/DSURs, RMP, emerging safety information (ESI) report, etc.) and other safety regulatory documents required to be submitted to Regulatory Authority.
• Manages cross-functional assessment of benefit-risk profile and communication of safety information for assigned compound(s) / product(s) and leads:
• the interpretation of safety data from internal and external sources
• assessment of ensuing scientific / medical implications
• communication of the impact of the above
• modification of development plan or study design, including potential impact on timeline or
• product labeling, ensuring patient safety
• The Sr Safety Physician assists in the successful development, execution and maintenance of safety-related strategies, processes and systems that conform to the company's business strategy, industry standards and compliance with global regulations
• Supporting the execution of clinical studies by:
• overseeing the completion of study specific Safety Management Plan,
• reviewing the safety section of clinical study protocol before its finalization,
• ensuring the Reference Safety Information is identified for review,
• creating study specific documents as applicable
• Coordinating the writing of DSUR
• Ensuring SAE/SUSAR/ADR/SADR, Safety information properly managed all over the study.
• Ensuring the completion of period reports to investigators, competent authorities and ethical committees upon request
• As needed, conduct medical review of individual case safety reports (ICSRs) including identification of appropriate follow-up requests of important medical information for the proper medical assessment and evaluation of cases.
• Ensures high quality analyses of safety information, in support of:
• safety update regulatory submissions
• investigational / new drug applications (NDA submissions)
• interactions with regulatory authorities worldwide
• Interacts with the PV Scientist responsible for overseeing the medical safety profile for assigned product(s)
• Interacts with colleagues from other functions to ensure the successful development, design and implementation of comprehensive safety and benefit-risk assessment strategies for products
• Represents the cross-functional program team as a product safety profile and risk mitigation expert for internal / external stakeholders
• Manages the reactive response to emerging safety signals
• Maintains professional knowledge and fosters a community of continual learning

Qualifications

• M.D./D.O Degree
• Minimum of 10-12 plus years of medical safety/ pharmacovigilance experience
• Minimum of 6-8 plus years of experience with concepts of signal detection and review of aggregate data to identify potential emerging safety issues, benefit-risk assessment, and risk management strategies
• Knowledge of clinical development process
• Experience in the preparation and contribution to authoring aggregate safety reports for regulator submission(NDA)
• Exposure to working relationship with the FDA and other regulatory authorities
• Demonstrated ability to prioritize multiple tasks and deliver to deadline with high standard of quality
• Experience with commercially available safety databases
• At least three years of practical clinical experience post licensure
• Knowledge of drug approval processes in major countries

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Menarini Stemline is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.