Global Safety Lead (MD)

Stemline Therapeutics; United States; On-site; USD 80,000 - 100,000; Full time

Job summary

An established industry player in the biopharmaceutical sector is seeking a Global Safety Lead/Senior Safety Physician to oversee safety strategies for its oncology portfolio. This pivotal role involves managing the safety surveillance and risk communication for assigned products, ensuring compliance with regulatory standards, and collaborating with cross-functional teams. The ideal candidate will have extensive experience in pharmacovigilance and a strong medical background, ready to contribute to innovative oncology solutions. Join this dynamic team and play a key role in shaping the future of patient safety in oncology.

Qualifications

• 10-12 years of medical safety/pharmacovigilance experience required.
• Experience with signal detection and aggregate data review is essential.

Responsibilities

• Oversee safety strategy for assigned products and manage risk-benefit profiles.
• Ensure submission of aggregate safety reports to regulatory authorities.

Skills

Medical Safety Expertise

Pharmacovigilance

Risk Management

Signal Detection

Clinical Development Knowledge

Regulatory Submission Experience

Prioritization Skills

Education

M.D./D.O Degree

Tools

Safety Databases

Job description

Overview

Global Safety Lead/Senior Safety Physician

Reports to Head of Medical Safety

Founded in 1886 in Naples under the name of Farmacia Internazionale, Menarini moved in 1915 to Florence where the Group’s headquarters are still located today. High quality therapeutics and diagnostics solutions for patients, ethics as our underlying principle, dedication to innovation and advancement, strong people centricity and environmental sustainability. These five pillars form the foundation of the Menarini Group, an Italian pharmaceutical company with nearly 135 years of history.

The Menarini Group is present in 70 countries and our products are sold in 140 locations around the world. Its companies span from Europe to Asia, to Africa and the Middle East, to Central America and to the United States where with the acquisition of Stemline Therapeutics, a NASDAQ-listed biopharmaceutical company, the company marked its entry into the US oncology market.

Menarini has made a strong commitment to oncology, investing in a pipeline of five investigational compounds for the treatment of a variety of haematological and solid tumours. The acquisition of Stemline Therapeutics in June 2020, further strengthened Menarini’s oncology portfolio, adding both commercial and clinical-stage assets.

It is an exciting time in the company’s development and an excellent opportunity for individuals joining us to contribute to building and shaping Menarini Stemline’s Oncology business.

Opportunity

The Global Safety Lead (GSL) is a senior drug safety expert/physician who is responsible 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).

Responsibilities

• 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.
• 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).
• 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.
• 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 and interactions with regulatory authorities worldwide.
• Interacts with the PV Scientist responsible for overseeing the medical safety profile for assigned product(s).
• Represents the cross-functional program team as a product safety profile and risk mitigation expert for internal/external stakeholders.
• 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 essential functions.

Menarini Stemline is an equal-opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.