Pharmacovigilance Specialist
hace 3 semanas
The Pharmacovigilance (PV) Technician will play a crucial role in maintaining and improving the pharmacovigilance system at the PV Department at the Spanish affiliate. This position will be responsible for performing, planning, and assisting in the day-to-day work at the PV department.
Key Responsibilities
• Monitor PV mailbox and other communication channels for incoming ICSRs on drugs and parapharmaceuticals, including medical devices, cosmetics, and food supplements.
• Manage ICSR and CSR reconciliations with applicable stakeholders.
• Assist in reviewing PV SOPs and other department's SOPs for alignment.
• Directly involved in the continuous improvement work with regards to local PV procedures and tools, including writing local SOPs, work instructions, and job aids.
• Actively participate in audits and inspections.
• Perform local quality and compliance (QC) work, taking corrective and preventive actions as needed, including completion of deviation forms (PIFs), tracking, and documentation.
• Support Corrective Action and Preventive Action (CAPA) plans and continuous improvement work within the PV area.
• Assist in Risk Management Plan activities and Direct Healthcare Professional Communications (DHPC).
• Identify, negotiate, and establish applicable pharmacovigilance agreements, maintaining them updated.
• Assist in CEP (Customer Engagement Program) activities, such as digital media, Market Research Programs, and Patient Support Programs.
• Assist in local PSUR/ACO work.
Requirements
The ideal candidate should have strong analytical and problem-solving skills, with the ability to work independently and as part of a team. Strong communication and interpersonal skills are also essential.
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