Job
Description
Role & responsibilities Lead, mentor, and manage the Pharmacovigilance QA team to ensure effective execution of QA activities. Develop, implement, and maintain QA processes, procedures, and tools aligned with regulatory guidelines (e.g., ICH, FDA, EMA). Monitor and ensure compliance of pharmacovigilance activities with applicable regulations and internal SOPs. Conduct risk assessments and develop mitigation plans to ensure PV compliance . Oversee the management and closure of CAPAs (Corrective and Preventive Actions) following audits or inspections. Plan, coordinate, and conduct internal and external audits of PV processes, systems, and vendors audits ( Risk Based Audit approach ). Lead audit preparedness activities and ensure timely resolution of audit findings. Collaborate with cross-functional teams to implement audit recommendations and continuous improvements. Maintain audit documentation and track audit metrics for management review. Ensure all QA activities support compliance with global pharmacovigilance regulations, including GVP (Good Pharmacovigilance Practices). Participate in regulatory inspections and provide QA support as needed. Review and approve quality documentation related to PV activities such as SOPs, training materials, and audit reports. Identify QA training needs for the PV team and develop training programs accordingly. Conduct and coordinate training sessions on quality standards, SOPs, and compliance requirements. Promote a quality culture and awareness within the PV department. Identify gaps and areas for improvement within PV and QA processes and implement best practices. Collaborate with PV operations and other departments to optimize workflows and enhance quality outcomes. Utilize metrics and KPIs to monitor quality performance and drive continuous improvement. Act as the key liaison between PV, QA, regulatory affairs, and other stakeholders. Provide guidance and support on quality-related matters to internal teams and external vendors. Facilitate effective communication to ensure alignment on quality expectations and deliverables. Plan, assign, and review work for QA team members and provide ongoing feedback and development opportunities. Facilitate team meetings and promote continuous communication and knowledge sharing within the team. Support recruitment, onboarding, and performance management of QA staff. Preferred candidate profile Bachelors degree in Pharmacy, Life Sciences, or related field (Master’s preferred). Extensive experience (typically 7+ years) in Pharmacovigilance with significant exposure to QA activities. Strong knowledge of global pharmacovigilance regulations, GVP, and quality management systems. Proven leadership and team management skills. Experience in conducting audits and managing CAPAs . Excellent communication, organizational, and problem-solving skills. Ability to work collaboratively with cross-functional teams and external vendors.
