This Job Vacancy has Expired!

(Senior) Director, Pharmacovigilance & Risk Management

Posted on Apr 6, 2021 by Biontech

Cambridge, MA 02138
Immediate Start
Annual Salary

Set up and implement the next level-strategy for our global pharmacovigilance and safety operations for a portfolio of products/programs, ensuring the development of safety processes, tools and system implementation
Strategically develop and implement post-marketing pharmacovigilance processes and contribute to the product specific Risk Management Plan
Represent BioNTech on co-development teams for assigned products/programs and liaison with co-development partners to ensure coordinated safety reporting activities
Provide guidance to product/program teams and CROs for safety case review and adjudication
Participate in the review and interpretation of clinical trial results, particularly for understanding and interpretation of product safety

What you have to offer.
PhD, Doctorate or Masters Degree in one of the following areas Medical (MD or equivalent), Nursing, Public Health or Pharmacy
At least 10 years of experience in pharmacovigilance, product safety and/or clinical operations within the biotech, CRO or pharmaceutical industry
Experience in designing or implementing safety reporting/safety management processes, systems and tools to support both case-level review and trend analyses
Ability to implement product and study-level risk assessment and risk mitigation into global drug development
Experience with oncology and/or rare disease product development, as well as analysis of biological treatments/ATMP is beneficial
Knowledge and experience in signal detection methodologies
Experience in managing teams responsible for safety operations and/or pharmacovigilance is required; readiness to take over QPPV responsibilities
Expert knowledge of global safety reporting regulations, including US, EU, and UK requirements
Knowledge in Regulatory audits and inspections, as well as management of partners and vendors

Reference: 1152694338

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