Drug Safety Manager (m/f/d)

Ort 64295 Darmstadt
Working time model Full-time
Contract typeEmployment agency

Your expertise. Our commitment to patient safety.

Would you like to do more than just manage pharmacovigilance – would you like to play an active role in shaping it? As a Drug Safety Manager – Pharmacovigilance (m/f/d), you will play a key role in our international drug safety team and help ensure that safety information is assessed quickly, accurately and in compliance with regulatory requirements.

We bring together scientific expertise, international collaboration and modern working methods.

What we offer you

  • A position of responsibility with a high profile within the company
  • An international and dynamic working environment
  • Flexible working hours and hybrid working models
  • Attractive remuneration and comprehensive benefits
  • Individual training and development opportunities
  • Occupational pensions and health benefits
  • A collegial corporate culture with short decision-making processes

Your responsibilities

You will play a key role in operational pharmacovigilance and work closely with international colleagues from Pharmacovigilance, Medical Affairs, Regulatory Affairs, Clinical Development and Quality.


Her areas of specialisation

  • Management and technical processing of Individual Case Safety Reports (ICSRs)
  • Medical and regulatory assessment of safety information
  • Ensuring quality, compliance and the timely processing of cases
  • Follow-up, Case Reconciliation and Duplicate Management
  • Monitoring of operational PV KPIs and timelines
  • Contributing to signal detection and signal management
  • Support with PSURs/PBRERs and other safety reports
  • Involvement in risk management activities
  • Support with audits and PV inspections
  • Coordination and management of international stakeholders and external PV partners
  • Active further development of processes, SOPs and operational PV standards

This is what you bring to the table

  • A degree in pharmacy, medicine, natural sciences, life sciences or a comparable subject
  • Several years’ professional experience in pharmacovigilance / drug safety
  • Extensive experience in the operational processing of ICSRs
  • A good understanding of EU GVP and ICH requirements
  • Experience with a safety database, ideally in an international pharmaceutical environment
  • Knowledge of signal management and/or PSUR/PBRER would be an advantage
  • A strong focus on quality and analytical thinking
  • Independent, structured, and solution-oriented approach
  • Confident communication with international stakeholders
  • Very good German and English language skills

You can reach us here with your questions!

Contact

Thilo Grünewald

Telephone 0151 1806 7001
Email: karriere-jobs@sandyou.de

Location

S&You Akademiestr. 49 76133 Karlsruhe

About S&You
S&You is a brand of the SYNERGIE Group – the fifth-largest recruitment agency in Europe. We help specialists and executives take the next step in their careers – offering a personalised, professional and expert service, exclusively through direct placement. Thanks to our many years of experience and international network, we are a key recruitment partner for many renowned companies. Make the most of our contacts and market knowledge!

Apply now