Global Pharmacovigilance/Safety Scientist

The Global Safety (PV) Scientist for large, late-stage or multiple early-stage programs works closely with the Global Safety Leader (GSL) and cross-functional team to proactively perform safety surveillance and risk management in support of benefit risk profile throughout the product life cycle.

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.

Responsibilities

• Supports the Global Safety Lead (GSL) for assigned Menarini-Stemline product(s)
• Responsible for safety surveillance, signal detection and risk management activities
• Supports cross-functional assessment of benefit-risk profile and communication of safety information for assigned Menarini-Stemline product(s)
• Provides pharmacovigilance functional area expertise and support to project teams for assigned developmental and/or marketed products
• Represent pharmacovigilance as an authoritative and knowledgeable member for the assigned MenariniStemline product(s) in collaboration with the GSL
• Coordinates all aspects of signal detection and safety surveillance and review activities, in collaboration with the GSL, for assigned product(s)
• Analyze and interpret safety data from various sources including non-clinical, clinical, post-marketing and scientific literature
• Facilitate ongoing safety surveillance for assigned product(s), assisting with / leading data collection and assessment
• Coordinate and perform signal identification, evaluation and management activities for assigned products, ensuring communication of all safety information that may impact the benefit-risk profile of assigned product(s) to senior management
• Assist with / lead authoring of safety evaluations: defining scope, methodology and providing background information for aggregate safety reports; conducting preliminary safety analyses; preparing ad hoc reports including Health Hazard Evaluations, Signal Evaluation Reports and Health Authority responses
• Partner with cross-functional colleagues and contribute to safety-related deliverables associated with new drug applications, benefit-risk assessments and activities related to risk minimization including RMPs
• Liaise with colleagues in relevant functional areas within / outside of Menarini-Stemline Global Drug Safety and Pharmacovigilance (MS GDSP) to gather / provide input for appropriate sections of critical documents (e.g., protocols and amendments, ICFs, IBs, core data sheets, IMPDs, CSRs, INDs, NDAs, BLAs and CTAs)
• Liaise with relevant functional areas within / outside of MS GDSP to best ensure the most efficient and timely attainment of compliant and patient focused safety data
• Represent MS GDSP in cross-functional teams / committees and external environments at a global / regional level as required, with the advanced communication skills this requires
• Assist with / lead the preparation / presentation of identified / potential patient safety risks and SMT recommendations on safety issues to cross-functional decision-making bodies / upper management
• May lead / assist presentations to cross-functional decision-making bodies / upper management
• Build / maintain in-depth knowledge/ understanding of designated product(s) / clinical studies / protocols to effectively respond to safety issues
• Ensure up-to-date representation of safety information in the product(s) Core Data Sheet (including Reference Safety Information), Investigator Brochure as well as other labeling documents
• Demonstrate proficient knowledge of local and global health authority requirements
• Support MS GDSP in the maintenance of a highly effective global safety organization in full compliance to worldwide regulations
• Train / mentor new / junior MS GDSP colleagues
• Maintains professional knowledge and fosters a community of continual learning within MS GDSP (e.g., protocols and amendments, ICFs, IBs, core data sheets, IMPDs, CSRs, INDs, NDAs, BLAs and CTAs)

Qualifications

• MS / MA / Advance degree in life sciences, biology or other healthcare related profession
• 5 years of experience in pharmacovigilance
• Knowledge of GCPs, ICH guidelines and FDA, EMA and other international regulations and guidelines
• Experience working with safety databases ((i.e., ARGUS, ARISg or other safety database applications), electronic data capture (EDC) systems and electronic document management systems
• Knowledge of GCPs, ICH guidelines and FDA, EMA and other international regulations and guidelines
• Working knowledge of MedDRA and WHO Drug dictionaries
• Excellent communicator, both oral and written, specifically medical writing skills
• Ability to critically analyze individual and aggregate safety data with scientific rigor
• Relationship building skills, with ability to interact effectively in a multifunctional and multicultural team setting
• Ability to work independently or as a member or leader of a project team
• Extensive experience in preparing global periodic safety reports, including strategizing and developing responses to questions from Health Authorities

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.