(Senior) Director, Pharmacovigilance & Risk Management*
- Cambridge, MA
- Senior, very experienced
- Executive Middle Management
- Research, development, teaching
(Senior) Director of Pharmacovigilance & Risk Management*
Based in Cambridge, MA, BioNTech US serves as BioNTech’s North American headquarters and is an important part of our global effort to pioneer the development of next-generation immuno-oncology therapies. BioNTech US is a fully integrated subsidiary with a strong foundation in Europe and a focus on the development of novel neoantigen-targeted T cell therapies, complementing BioNTech’s highly innovative scientific approach and diversified pipeline of transformative cancer medicines. As a key research and clinical development hub, BioNTech US will enable BioNTech’s growing presence in the US.
As a part of our team of more than 1.500 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age: Amongst multiple programs in the pipeline, we are conducting research on a Covid-19 vaccine in our project “Lightspeed” based on our mRNA-technologies. Furthermore, we are pioneers in the development of individualized cancer therapies and in the combat against other diseases.
We aim to achieve life-changing successes for patients by being innovative, passionate and united,so get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.
Here, you’ll achieve greatness.
- 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 Master's 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
Benefits for you.
- Medical, Dental and Vision Insurance
- Life, AD&D, STD and LTD Insurance
- HSA & FSA Spending Accounts
- Health & Wellness, including free onsite gym access
- Adoption & Surrogacy Assistance
- Vacation and Unlimited Sick Time
- Holidays and Floating Holidays, including discretionary winter shutdown
- 401(K) Plan with Significant Company Match
- Tuition Reimbursement and Professional Development
- Commuting Assistance and free onsite parking
- Discounted Home and Auto Insurance
- Pet Insurance
Have we kindled your pioneering spirit?
For those who require assistance due to disability, or have questions prior to applying, please email firstname.lastname@example.org.
*BioNTech does not differentiate on the basis of gender, race, religion, color, origin, sexual orientation, disability, age and other protected status as required by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer.
BioNTech - As unique as you