About Abbott :
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
Established Pharmaceuticals
We are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory.
Primary Job Function:
The Affiliate PV Staff in Republic of Korea is supporting the ASR in local pharmacovigilance activities related to both Abbott EPD investigational and registered medicinal products. The Affiliate PV Staff supports ASR to ensure all pharmacovigilance activities (especially ICSR management) are performed at Affiliate level in accordance with internal Abbott policies and procedures as well as with local regulatory requirements. This includes interactions with local health authorities and representation of pharmacovigilance internally within the Affiliate organization.
Core Job Responsibilities:
- Follow 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
- Support for coordination/management of PV audits and inspections at the Affiliate level
- Perform vigilance compliant to local legislation for Abbott EPD products beyond medicinal products such as medical devices and food supplements
- Support in preparation of Health Hazard Assessment/Medical Expert Statements
- Perform PV quality checks requiring four-eye review
Minimum Education:
Ideally graduate with a Life Sciences or Pharmacy degree or equivalent qualification
Minimum Experience/Training Required:
- PV experience in pharmaceutical company is preferred
- 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
