Safety Scientist (f/m/d) - QPPV-Office/Veterinary PV

B. Braun Group; Melsungen; Vor Ort; EUR 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

Corporate networks

Company pension scheme

Mobility benefits

Family & work-life offerings

Mobile working

Employee discounts

Zusammenfassung

B. Braun Melsungen AG is seeking a Safety Scientist (m/f/d) for the QPPV-Office at the Melsungen site to lead pharmacovigilance governance and ensure global oversight of the PV system for human medicines.

You will coordinate QPPV-related processes, promote compliance, and advance PV standards across the organization. The role encompasses governance, training oversight, KPI analysis, and collaboration with affiliates, PVAs, and SDEAs, while also handling veterinary PV activities and regulatory

Qualifikationen

• Degree in Human Medicine, Veterinary Medicine, Human Biology, or a comparable scientific discipline; or completed vocational training with several years of relevant professional experience in Quality Management, Drug Safety, or Pharmacovigilance.
• Good knowledge of EU pharmacovigilance legislation and Good Pharmacovigilance Practice (GVP) guidelines.
• Excellent written and spoken German and English language skills.
• Proficiency in Microsoft 365 applications.
• Affinity for IT-supported processes and interest in working with pharmacovigilance systems and tools.

Aufgaben

• Ensure PV governance and QPPV oversight through monitoring of regulatory requirements and coordination of implementation activities.
• Act as central point of contact for affiliates and distributors regarding governance, compliance, and QPPV-related matters.
• Ensure compliant delivery and documentation of pharmacovigilance training activities, including administration of training platform and development of e-learning modules.
• Collect and analyze compliance data to support QPPV oversight (KPIs).
• Support negotiation of Pharmacovigilance Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs).
• Prepare statistics, presentations, and analyses related to drug safety and QPPV oversight activities.
• Manage and respond to QPPV-related inquiries.
• Maintain and regularly update the Pharmacovigilance System Master File (PSMF).
• Coordinate pharmacovigilance audits and regulatory inspections.
• Coordinate and continuously improve business continuity measures for PV processes.
• Collect, document, assess, and report adverse events for veterinary medicines; prepare regulatory reports.

Ausbildung

Degree in Human Medicine, Veterinary Medicine, Human Biology, or a comparable scientific discipline; or vocational training with relevant experience

Tools

Microsoft 365

Jobbeschreibung

Within the Quality Management function of the Hospital Care division, the Global Pharmacovigilance and Patient Safety (GPVS) department of B. Braun Melsungen AG is seeking to appoint a Safety Scientist (m/f/d) for the QPPV-Office at the Melsungen site at the earliest possible date.

The QPPV-Office forms a central governance function within B. Braun's global pharmacovigilance system for human medicinal products. Together with the QPPV, the team ensures the compliant governance, continuous development, and effective oversight of the system. It is responsible for coordinating QPPV-related processes, promoting transparency regarding compliance and patient safety topics, and maintaining comprehensive oversight at a global level.

In addition, the QPPV-Office manages global matters within the QPPV‘s area of responsibility and drives the continuous enhancement of pharmacovigilance standards, processes, and governance structures.

The Veterinary Pharmacovigilance function manages the global pharmacovigilance system for veterinary medicinal products of B. Braun Melsungen AG. Among other responsibilities, the team is accountable for the continuous benefit-risk assessment of veterinary medicinal products, the fulfillment of regulatory reporting obligations, and the coordination of activities required to ensure the safety of veterinary medicinal products.

Duties And Responsibilities

QPPV-Office

• Ensure PV governance and QPPV oversight through monitoring of regulatory requirements, assessment of the impact of regulatory changes, and coordination of corresponding implementation activities
• Act as a central point of contact for affiliates and distributors regarding governance, compliance, and QPPV-related matters
• Ensure the compliant delivery and documentation of pharmacovigilance training activities, including administration of the training platform and development of e-learning modules for the Pharmacovigilance function
• Collect and analyze compliance data to support QPPV oversight, including Key Performance Indicators (KPIs)
• Support the negotiation of Pharmacovigilance Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs)
• Prepare statistics, presentations, and analyses related to drug safety and QPPV oversight activities
• Manage and respond to QPPV-related inquiries
• Maintain and regularly update the Pharmacovigilance System Master File (PSMF)
• Coordinate pharmacovigilance audits and regulatory inspections
• Coordinate and continuously improve business continuity measures to ensure the functionality of critical pharmacovigilance processes

Veterinary Pharmacovigilance

• Collect, document, assess, and report adverse events associated with veterinary medicinal products of B. Braun Melsungen AG
• Prepare process documentation and regulatory reports in accordance with applicable legal requirements

Professional Qualifications

• Degree in Human Medicine, Veterinary Medicine, Human Biology, or a comparable scientific discipline; alternatively, completed vocational training combined with several years of relevant professional experience in Quality Management, Drug Safety, or Pharmacovigilance
• Good knowledge of EU pharmacovigilance legislation and Good Pharmacovigilance Practice (GVP) guidelines
• Excellent written and spoken German and English language skills
• Proficiency in Microsoft 365 applications
• Affinity for IT-supported processes and interest in working with pharmacovigilance systems and tools

Benefits

• Corporate networks
• Company pension scheme
• Mobility benefits, e.g., the B. Braun job ticket or job bike
• Family & work‑life offerings, e.g., holiday childcare
• Mobile working
• Employee discounts

B. Braun Melsungen AG | Dennis Friedrich