Director PV Scientist Job at EPM Scientific, New York, NY

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  • EPM Scientific
  • New York, NY

Job Description

I am excited to be partnered with a growing biotech on their brand-new search for a Director of Pharmacovigilance!

This innovative biotech is revolutionizing the development of gene-edited CAR T-cell therapies. Using advanced technology, they create readily available immunotherapies designed to treat cancer patients more effectively. Their approach aims to provide widely accessible treatments by leveraging gene editing to enhance safety and efficacy. With a strong portfolio of patents and strategic global partnerships, they continue to push the boundaries of cell and gene therapy.

Reporting to the Chief Medical Officer, the Head of PV Sciences will oversee all activities related to drug safety performance. The primary goal is to ensure that patients, caregivers, investigators, site staff, and the clinical development team have the latest insights and information on the safety of the company's products and the appropriate actions to take if patient safety concerns arise during clinical trials.

You will be responsible for:

  • Leading and overseeing all activities to ensure the safety of patients participating in clinical trials and exposed to the company's products.
  • Ensuring the development and timely delivery of all required drug safety content and documents in compliance with regulatory authorities.
  • Implementing the most recent drug safety standards, techniques, and regulations across the company's pharmacovigilance activities.
  • Establishing procedures to address patient safety concerns and proactively integrating drug safety into drug development activities.

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