Global Safety Lead Position Available In New York, New York

ResponsibilitiesServes 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 productsEnsuring 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 sourcesassessment of ensuing scientific / medical implicationscommunication of the impact of the abovemodification of development plan or study design, including potential impact on timeline orproduct labeling, ensuring patient safetyThe 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 regulationsSupporting 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 submissionsinvestigational / new drug applications (NDA submissions)interactions with regulatory authorities worldwideInteracts 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 stakeholdersManages the reactive response to emerging safety signalsMaintains professional knowledge and fosters a community of continual learningQualifications

M.D./D.O

DegreeMinimum of 10-12 plus years of medical safety/ pharmacovigilance experienceMinimum 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 strategiesKnowledge of clinical development processExperience 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 qualityExperience with commercially available safety databasesAt least three years of practical clinical experience post licensureKnowledge of drug approval processes in major countriesMenarini Stemline is 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.

Minimum Salary:

250,000

Maximum Salary:

320,000

Salary Unit:

Yearly