Local Pharmacovigilance Responsible Person- 12 months contract (part-time)

Role Summary:

Serve as the designated Local Contact Person for Pharmacovigilance (LCPP) in Germany, ensuring compliance with German and EU pharmacovigilance regulations. Act as the primary liaison with local health authorities and support the Qualified Person for Pharmacovigilance (QPPV) in maintaining the pharmacovigilance system. Additionally, lead global process ownership for assigned PV processes, driving standardization and continuous improvement across regions.
Key Responsibilities:

Local Pharmacovigilance Responsibilities (Germany):

• Act as the Local Contact Person for Pharmacovigilance in Germany, available 24/7 for urgent safety issues.
• Ensure compliance with German PV requirements, including local reporting obligations and maintenance of local PV documentation.
• Serve as the primary interface with German health authorities (e.g., BfArM) for pharmacovigilance-related queries and inspections.
• Maintain awareness of local regulatory changes and implement necessary updates to PV processes.
• Support the EU QPPV in oversight of the PV system and ensure alignment with the Pharmacovigilance System Master File (PSMF).

Global Process Owner Responsibilities:

• Own and manage assigned global PV processes (e.g., safety agreements, PSMF maintenance, risk management), ensuring consistency and compliance across regions.
• Develop and maintain global SOPs, templates, and guidance documents for assigned processes.
• Drive process improvements and harmonization initiatives in collaboration with cross-functional teams.
• Provide expert advice and training to internal stakeholders on global PV processes.

Additional Responsibilities:

• Prepare and maintain PSMFs and local annexes for Germany.
• Oversee development and negotiation of pharmacovigilance agreements for assigned clients.
• Act as EU QPPV for small clients, where applicable.
• Mentor and train team members on PV processes and regulatory requirements.
• Support audits and inspections at global and local levels.

Qualifications:

• Education: Bachelor's degree in Life Sciences, Pharmacy, Medicine, or related field (advanced degree preferred).
• Experience:
  • Minimum 5 years in pharmacovigilance or drug safety within a pharmaceutical company or CRO.
  • At least 3 years of experience in PV system management and regulatory compliance.
  • Previous experience as LCPP or similar role in Germany strongly preferred.
• Knowledge:
  • In-depth understanding of EU and German PV regulations (GVP Modules, AMG requirements).
  • Strong knowledge of PV agreements, PSMF, and risk management processes.
• Skills:
  • Excellent communication skills in English and German (written and verbal).
  • Strong organizational and time management skills; ability to manage multiple priorities.
  • Effective stakeholder management and relationship-building skills.
  • Ability to lead process improvement initiatives globally.

Additional Requirements:

• Availability for 24/7 contact as required by German PV regulations.

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