AD Pharmacovigilance

Associate Director Pharmacovigilance Operations

Flexibility: Hybrid role, 3 days in office

Location: Aachen

About the company:

A speciality pharmaceutical company with innovative drugs to be used in hospitals with products across the selected European markets with additional products approved in the U.S., the EU/EEA/UK, China and South Korea.

About the role:
The Associate Director of Pharmacovigilance Operations is responsible for ensuring that all aspects of safety reporting in relation to marketed and development products are met, pharmacovigilance (responsibilities from third-party agreements are fulfilled, and overall compliance with documented procedures and regulatory obligations according to European and ICH guidelines, as well as globally agreed standards, is maintained.

Your tasks & responsibilities:

• Collaborate with external PV Operations teams to develop, maintain, and continuously improve effective systems for single case processing and reporting, fulfilling requirements for signal detection and aggregate report compilation.
• Develop and assess compliance metrics and ICSR quality control (in cooperation with QA).
• Ensure compliance with all applicable laws, guidance, and business processes.
• Act as the subject matter expert for PhV Operations during audits and regulatory inspections.
• Facilitate issue resolution across functions and partner organizations.
• Provide strategic direction across internal functions and external PhV alliance partners.
• Assist PhV management with policy and process changes.
• Assist in resource forecasting and support PhV management in allocating internal and vendor resources to meet demand.
• Escalate relevant issues (e.g., non-compliance, inadequate resources) to senior management and assist in resolution.
• Promptly communicate planned PhV Operations procedural and/or structural changes to key stakeholders.
• Support QA in generating and managing the PhV training process.

Your profile:

• Bachelor’s degree in a health science area (e.g., Nursing, Pharmacy).
• Minimum of 5 years of experience in PV operations within the pharmaceutical or biotechnology industries or CROs.
• Pre- and post-marketing experience in setting up PhV processes.
• Knowledge of PhV requirements and legislation for drug development and regional PhV experience.
• Experience using a defined terminology (MedDRA) for coding medical terms.
• Advanced level in written and spoken English