Job Description

Mainz, Germany; London, United Kingdom; Munich, Germany | full time | Job ID: 9669





The Associate Director of Pharmacovigilance Safety Systems serves as the subject matter expert for pharmacovigilance (PV) safety systems, bridging business and technical expertise. This position acts as the primary point of contact for the PV safety system, managing frequent system releases and ad-hoc configurations. The Associate Director of Pharmacovigilance Safety Systems builds and maintains the business administrator library, ensures data integrity, and supports the validated state of the safety database for strategic partnerships.

Your main responsibilities are:

Serve as the primary point of contact for pharmacovigilance (PV) safety system users, possessing comprehensive knowledge of the technical aspects, system configuration, as well as PV regulations and processes, to effectively support system-related business operations Facilitate strategic co-development partnerships with a focus on various PV system aspects, including data provision, gateway management, and system configuration Oversee system implementations, releases, connections and improvements within cross-functional teams, engaging both with internal and external stakeholders. This involves identifying, centralizing, and prioritizing business requirements and translating them into technical specifications Maintenance and improvement of business admin system library (e.g. management of products, studies, datasheets, reporting rules, registrations) Coordinate complex single case processing reporting scenarios of co-development investigational products between partners Develop and implement strategies for the continuous improvement of processes and systems, working closely with clients, while adhering to existing PV regulations and processes to optimize cost reduction and enhance business value Author and review system-specific quality documents, including guidance documents and training materials Organize and facilitate system related training sessions Coordinate and perform user acceptance testing Maintain the validated state and ensure data integrity of the systems, contributing to the scope of PV inspections conducted by health authorities and partners

What you have to offer.

University degree in Medicine, Life Sciences, or Pharmacy; Medicine preferred More than 10 years of experience in pharmacovigilance in the pharmaceutical industry Demonstrated experience in managing strategic partnerships within the pharmaceutical industry, showcasing a proven ability to foster collaborative relationships and drive joint initiatives Demonstrated strong experience with Veeva Vault Safety implementation and maintenance including system connections Hands-on experience in operating PV systems, conducting user training, and authoring procedural documents Capability to collect business requirements and effectively translate them into technical specifications Proficient knowledge of Good Pharmacovigilance Practices (GVP) and global PV regulations and processes Proficiency in computer system validation and the management of computerized systems in a GxP environment Fluency in English is essential, while proficiency in German is considered beneficial Competence in using common software tools such as Word, Excel, and PowerPoint Exceptional interpersonal, communication, and organizational skills

Your Benefits:

It's our priority to support you:


Your flexibility: flexible hours | vacation account Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential Your health and lifestyle: Company bike Your mobility: Job ticket | Deutschlandticket Your life phases: Employer-funded pension | Childcare

Apply now - We look forward to your application!

Apply to our Mainz, Germany; London, United Kingdom; Munich, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 12 PM to 4 PM CET).




Job ID 9669 (please always specify if you have any questions)




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.

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