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Pharmacovigilance Operations Manager (M/F/D)
Tasks:
Manage global pharmacovigilance (PV) partners and vendors to ensure compliance with SOPs, KPIs, PV agreements, and contracts
Create and update SOPs, work instructions, and procedural documents
Process Oversight and Optimization e.g. support CAPA implementation
Oversee case management activities
Assist with audit/inspection responses
Contribute to the creation and maintenance of PV contractual agreements
Assist in developing and maintaining a global PV system
Develop and continuously improve pharmacovigilance processes, including the drafting and revision of SOPs and work instructions
Collect, analyze, and interpret PV-related data to create reports and presentations that deliver performance insights and support decision-making
Qualification:
Academic background in life sciences, medicine, or pharmacy
Minimum of 4 years of professional experience in drug safety and pharmacovigilance
Fulfilling the role of the German Deputy Graduated Plan Officer (stellv. Stufenplanbeauftragte) according to §63a of the German Drug Act
Familiarity with global regulatory requirements related to Good Pharmacovigilance Practices (GVP), including practical experience in safety reporting for clinical trials, post-marketing surveillance, case processing, and submissions to regulatory authorities worldwide
Strong background in working with safety and quality systems such as Argus Safety and Veeva Vault QMS, along with experience in compliance tracking and monitoring key performance metrics
English business fluent, proficiency in German is an advantage
Requirements:
Start: June 2025
Duration: 6 months
Capacity: 5 days per week
Location: Remote
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