Job Description

The role of Pharmacoviligence Specialist ensures that all activities related to pharmacovigilance (PV) for both Abbott EPD investigational and registered medicinal products are performed at Affiliate level in accordance with internal Abbott policies and procedures as well as with local regulatory requirement.

What You’ll Do:

• 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.