Director/ Senior Director, Pharmacovigilance

Company Background

Tessa Therapeutics is a clinical-stage immunotherapy company focused on the development of autologous and off-the-shelf, allogeneic therapies targeting solid tumors. Tessa’s Virus-Specific T cell (VST) platform harnesses the body’s potent anti-viral immune response and has shown compelling results in the treatment of solid tumors.

Tessa is building a portfolio of innovative, next-generation therapies by combining the qualities of VSTs with other immuno-oncology technologies. This includes a rapidly growing pipeline of clinical and pre-clinical autologous programs that target a wide range of cancers, including nasopharyngeal carcinoma, cervical cancer, oropharyngeal cancer, lung cancer, breast cancer, bladder cancer, as well as head and neck cancer. In addition, Tessa is leveraging its platform to develop an allogeneic therapy to address Epstein-Barr virus (EBV)-associated lymphomas.

Tessa has built up robust operational and supply chain capabilities to successfully deliver T cell therapy treatments to a large patient pool worldwide. Together with the Company’s academic, clinical, and commercial research partners, Tessa has created a fully-integrated approach to the treatment of cancer with immunotherapy.

Our mission is to cure cancers and save lives with our innovative and widely accessible immunotherapies. We are looking for highly motivated and enthusiastic individuals who are interested to be part of our team.

Job Position
Director/ Senior Director, Pharmacovigilance

Reports to
Vice President, Regulatory Affairs

Job Description

  • Responsible for developing and ensuring execution of all patient safety risk management activities for all products under development.
  • Perform drug safety signal detection activities for Tessa’s products; develop medically reasonable evaluations of safety signals; make specific, actionable and defensible recommendations for confirmation or refutation of safety signals.
  • Medically review individual case safety reports in conjunction with Clinical Development to ensure high-quality reports.
  • Lead the Safety Management Team for periodic review of safety data of Tessa products with Clinical Development, Statistics, Regulatory Affairs and other functions.
  • Review emerging literature for Tessa products to identify new and important information that potentially impact human safety.
  • Drive preparation of IND Annual Reports, and/or Development Safety Update Reports (DSUR’s) for Tessa products.
  • Participate in the development and production of integrated summaries of safety, clinical overviews and other health authority documents in conjunction with Clinical Development, Statistics, Regulatory Affairs, Medical Writing and other functions as needed.
  • Drive the safety strategy for Reference Safety Information for Tessa products, including Investigator Brochures and new labeling (e.g. US Package Insert, Summary of Product Characteristics or Core Data Sheet) in the context of multidisciplinary groups within Tessa.

Requirements

  • Health care professional with post graduate qualification (MD or equivalent)
  • Minimum of 10 years of Pharmacovigilance experience in Clinical Safety, including thorough knowledge of FDA and ICH safety reporting regulations and guidelines
  • Sound medical judgement and decision-making capabilities
  • Ability to work effectively within a team environment
  • Proficient in computer skills such as Microsoft Word, Excel and PowerPoint
  • Excellent verbal and written communication skills