Senior Pharmacovigilance SpecialistAbbott

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  Acts as a local QPPV on a 24/7/365 basis in EAC Affiliate.
• Maintenance of the Affiliate PV System Country Chapter and additional local PV procedures, forms, and templates
• PV business continuity planning and notification of any business interruptions that pose a threat locally or globally to pharmacovigilance processes or endanger regulatory compliance
• Receipt, recording, and reconciliation of safety information
• Safety surveillance including literature and health authority website screening and preparation of local periodic safety reports and Risk Management Plans
• Regulatory submission of safety information
• Basic PV training of local EPD staff
• PV record retention and archiving
• Implementation of out-of-office coverage for receiving and recording safety-relevant information
• Maintenance of local PV product list
• Ensure PV matters in local interventional studies and local non-interventional organized data collection schemes.
• Negotiation and implementation of local commercial pharmacovigilance agreements and local pharmacovigilance service agreements
• Due Diligence for product acquisition or in-licensing negotiated by an Affiliate organization.
• Provision of local PV Compliance metrics and management of non-compliances
• Coordination/management of PV audits and inspections at the Affiliate level
• Ensure vigilance compliant to local legislation for Abbott EPD products beyond medicinal products such as medical devices and food supplements.
• Contribution to benefit-risk assessment of the Abbott EPD products portfolio;
• Act as the key expert for any PV-relevant topics and ensures proactive communication as appropriate;
• Leading regional PV projects and contribution to global PV projects.

Required Qualifications

• Pharmacy or related health science degree

Preferred Qualifications

• At a minimum 4 years PV experience in pharmaceutical industry or PH Health authority. .
• Profound understanding of local PV regulation
• Ability to give attention to the detail.
• Computer literacy (Windows, MS Office)
• Good English language skills
• Good communication skills with internal and external stakeholders
• Excellent time management, organizational and planning skills.
• The ability to work independently and as a part of a team.
• Independent thinker with the ability to challenge the status quo with outstanding interpersonal skills.