Medical Director, Pharmacovigilance (Consultant)

Job Description:

About Allogene:

Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on X (formerly Twitter) and LinkedIn.

About the role:

Allogene Therapeutics is seeking a highly motivated Pharmacovigilance Consultant in the Safety and Pharmacovigilance team. The ideal candidate is an individual who is interested in working in a fast-paced, dynamic, and highly collaborative biotech environment with a willingness and ability to successfully take on new challenges.

Responsibilities include, but are not limited to:

• Perform medical review. Thoroughly evaluate the medical details of reported adverse events from clinical trials to determine severity, causality, and potential safety concerns.
• Monitor safety data for emerging patterns or trends (safety signals) that may indicate a potential safety issue with a drug and conduct further analysis to evaluate the signal's validity.
• Contribute to the development and implementation of risk management plans (RMPs), including risk mitigation strategies and communication plans for identified safety concerns.
• Provide medical expertise to internal and external stakeholders on drug safety issues.
• Other duties as assigned

Position Requirements & Experience:

• Medical degree (MD) with a strong clinical background
• Experience in clinical practice or clinical research is preferred
• Experience in oncology and/or cell therapy is strongly preferred
• Thorough understanding of pharmacovigilance principles, global regulatory requirements, and MedDRA coding
• Must be proficient in Argus
• Excellent analytical and critical thinking skills to evaluate complex medical data
• Strong communication and collaboration skills to effectively interact with cross-functional teams
• Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
• Ability to work independently and as part of a team
• Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
• Candidates must be authorized to work in the U.S.

We offer a chance to work with talented people in a collaborative environment. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.

As an equal opportunity employer, Allogene is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.

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