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Company Description
PRIMARY FUNCTION:
Responsible to ensure that all aspects of Pharmacovigilance at the affiliate level meets AbbVie’s statutory and ethical responsibilities, and complies with local and regional PV regulations, for the applicable product portfolio. Acts as the Affiliate’s lead for pharmacovigilance matters with the National Regulatory Agency and AbbVie PPS (Pharmacovigilance and Patient Safety) function.
To provide strategic leadership to manage and support the Pharmacovigilance (PV) team in executing assigned responsibilities.
Serve as the local Qualified Person for Pharmacovigilance (QPPV) in Colombia, Panamá, El Salvador & NQPPV Back-up in Perú and Guatemala, with sufficient authority to influence the performance of the quality system and pharmacovigilance activities and to promote, maintain and improve compliance with the legal requirements.
RESPONSIBILITIES:
Leadership and management
- Build and maintain effective business relationships across the affiliate to support the implementation of patient safety standards.
- Support recruitment, on-boarding,
training, development through coach and mentoring, performance management, and succession planning of appropriately skilled PV staff.
- Lead a diverse and remote team operating across multiple geographical locations.
- Communicate effectively to achieve affiliate/regional/area cross-functional alignment and engagement for a better understanding of the PV hub model and how to leverage it for success.
Oversight of the Pharmacovigilance System:
- Ensures that PV processes, procedures and systems are in place to comply with AbbVie General PV procedures and with local and/or regional PV regulations
- Maintain oversight of the performance of all activities that fulfil local and applicable regional PV regulations, including those performed by Regional PV Teams and/or outsourced partners..
- Maintains oversight of AbbVie’s PV system master file (PSMF) with the authority to ensure that the information
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📌 Pharmacovigilance Manager Latam Region North (Bogotá)
🏢 Abbvie
📍 Bogotá
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