Medizin und Pharma
Drug Safety Manager (gn)
München (81249), DeutschlandVor OrtArbeitnehmerüberlassungStart 12/2025
Eingestellt von
SThree_Germany
Ansprechpartner
Stefan Blochl
Projekt-ID
2936444
AuditsBiologieProzessoptimierungPharmakovigilanzMarktforschung
Beschreibung
Drug Safety Manager (gn)
Location: Munich | Department: Pharmacovigilance | Start: ASAP
Your Mission:
As a Local Safety Officer (LSO), you will play a key role in ensuring drug safety. You will guarantee compliance with local and global regulatory requirements and actively contribute to the continuous improvement of our European PV system.
Your Responsibilities:
Stay ahead of regulations: Monitor local pharmacovigilance requirements assess their impact, and keep our global PV team informed.
Drive process excellence: Support global PV initiatives and ensure smooth local implementation of new processes and standards.
Maintain compliance: Update local procedures to align with regulatory changes and company policies.
Ensure accurate reporting: Oversee vendors and manage the collection, translation, and submission of safety reports with precision and quality.
Collaborate effectively: Work closely with internal teams and external partners to reconcile safety data and maintain transparent communication.
Monitor scientific literature: Review local publications for potential adverse drug reactions related to our products.
Manage agreements: Prepare and implement pharmacovigilance agreements with license partners and service providers.
Implement risk measures: Execute additional risk minimization strategies and manage DHPC communications as required.
Support affiliate activities: Advise on PV needs for local projects, studies, and partnerships to ensure compliance from the start.
Evaluate programs: Assess patient support initiatives, market research, and digital projects for PV compliance.
Keep systems updated: Provide accurate local data for the Pharmacovigilance System Master File (PSMF).
Track performance: Generate KPIs and reports to keep stakeholders informed about PV activities.
Audit readiness: Lead preparations for audits and inspections, manage CAPAs, and ensure timely resolution of deviations.
Your Profile:
Interested?
Apply now!
SThree_Germany is acting as an Employment Business in relation to this vacancy.
Location: Munich | Department: Pharmacovigilance | Start: ASAP
Your Mission:
As a Local Safety Officer (LSO), you will play a key role in ensuring drug safety. You will guarantee compliance with local and global regulatory requirements and actively contribute to the continuous improvement of our European PV system.
Your Responsibilities:
Stay ahead of regulations: Monitor local pharmacovigilance requirements assess their impact, and keep our global PV team informed.
Drive process excellence: Support global PV initiatives and ensure smooth local implementation of new processes and standards.
Maintain compliance: Update local procedures to align with regulatory changes and company policies.
Ensure accurate reporting: Oversee vendors and manage the collection, translation, and submission of safety reports with precision and quality.
Collaborate effectively: Work closely with internal teams and external partners to reconcile safety data and maintain transparent communication.
Monitor scientific literature: Review local publications for potential adverse drug reactions related to our products.
Manage agreements: Prepare and implement pharmacovigilance agreements with license partners and service providers.
Implement risk measures: Execute additional risk minimization strategies and manage DHPC communications as required.
Support affiliate activities: Advise on PV needs for local projects, studies, and partnerships to ensure compliance from the start.
Evaluate programs: Assess patient support initiatives, market research, and digital projects for PV compliance.
Keep systems updated: Provide accurate local data for the Pharmacovigilance System Master File (PSMF).
Track performance: Generate KPIs and reports to keep stakeholders informed about PV activities.
Audit readiness: Lead preparations for audits and inspections, manage CAPAs, and ensure timely resolution of deviations.
Your Profile:
- Bachelor's degree in Life Sciences, Pharmacy, or Medical Sciences
- Solid knowledge of local, European, and international PV regulations
- Fluent in German and proficient in English
- Strong organizational skills and experience in cross-functional collaboration
- Analytical mindset with problem-solving abilities
- Excellent communication skills and ability to work in a culturally diverse environment
Interested?
Apply now!
SThree_Germany is acting as an Employment Business in relation to this vacancy.