Drug Safety Manager

Vor 6 Tagen

Munich, Bayern, Deutschland Progressive Vollzeit 80.000 € - 120.000 € pro Jahr

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:

  • 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

Desired Skills and Experience
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

SThree_Germany is acting as an Employment Business in relation to this vacancy.

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