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Director/ Senior Director, Pharmacovigilance

Tessa Therapeutics Ltd

This is a Contract position in South Brunswick, NJ posted March 25, 2020.

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