Drug Safety Manager (gn)

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!

Seniority level

Mid‑Senior level

Employment type

Full‑time

Job function

Health Care Provider

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