Support the evaluation and qualification of vendors, partners, and external organizations involved in PV activities.
Conduct and/or assist with supplier pre-qualification surveys.
Create and maintain vendor organization records related to PV activities within the Quality Management System (QMS).
Assist in ensuring adverse events (AE) reporting requirements are clearly defined within contracts and agreements.
Support the development, implementation, and review of pharmacovigilance Standard Operating Procedures (SOPs).
Collaborate cross-functionally with internal PV, clinical, regulatory, and medical teams to ensure compliance with contractual obligations and regulatory requirements.
Where applicable, assist with conducting external audits of PV vendors, CROs, Specialty Pharmacies, and monitoring organizations, including reporting and tracking CAPAs.
Support risk-based quality system approaches in line with post-marketing Good Pharmacovigilance Practices (GVP).
Requirements:
Basic knowledge of pharmacovigilance principles and AE reporting requirements.
Basic knowledge of vendor management and contract management in relation to PV activities (, Patient Support Programs, Specialty Pharmacies, Market Access, Market Research, Named Patient Programs).
Understanding of safety clauses in agreements, including Safety Data Exchange Agreements (SDEA), Master Service Agreements (MSA), and Statements of Work (SOW).
Familiarity with global PV regulations and guidelines (FDA, EMA, ICH).
Preferred: Experience in SOP development, process review, and PV/clinical/regulatory documentation.
Preferred: Experience conducting audits of PV vendors, CROs, and Specialty Pharmacies, with the ability to write audit reports and track CAPAs.
Strong organizational, analytical, and communication skills.
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