Manager Pharmacovigilance Alliances and Regions (fixed-term contract)
Mainz, Germany; London, United Kingdom | full time | Job ID: 11885
About the role:
As a Manager Pharmacovigilance Alliances and Regions, you will support the establishment, maintenance and oversight of pharmacovigilance alliances, safety vendors and regional pharmacovigilance activities. You will help ensure compliant implementation of pharmacovigilance agreements, vendor oversight processes and collaboration frameworks in accordance with applicable regulations, industry standards and BioNTech procedures.
You will work closely with internal stakeholders, business partners and service providers to ensure effective pharmacovigilance governance, compliance oversight and regional implementation of safety processes, including support for local post marketing activities.
Your contribution:
- Support maintenance and lifecycle management of Pharmacovigilance Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs), including associated pharmacovigilance contractual obligations
- Support oversight of assigned pharmacovigilance vendors and business partners, including reconciliation activities, agreement implementation and governance activities
- Coordinate required pharmacovigilance training activities for vendors and partners in collaboration with the responsible training function
- Monitor compliance related activities, investigate and follow up reconciliation discrepancies, and escalate operational issues where appropriate
- Support qualification, onboarding and implementation of pharmacovigilance processes for new vendors and business partners and maintain PVA governance documentation and trackers
- Collaborate with Legal and Procurement on PV contractual requirements, contribute to PV procedures, and support audits, inspections and regional implementation activities
A good match:
- A master’s degree or equivalent in medicine, pharmacy, natural sciences or life sciences
- Experience in pharmacovigilance or clinical trials in the pharmaceutical, biotechnology or contract research organization sector
- Experience supporting pharmacovigilance vendor oversight or business partner management
- Knowledge of Good Clinical Practice, Good Pharmacovigilance Practices and related global regulations
- Business-fluent written and spoken English, with strong communication and collaboration skills
- Confidence using Word, Excel and PowerPoint, and the ability to work effectively with colleagues, partners and vendors
This position is a two-year fixed-term contract.
Your benefits:
BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.
Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.
How to apply:
Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.
Please note:
Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.
We are looking forward receiving your application.