Pharmacovigilance Coordinator

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

PRIMARY FUNCTION:

Lead the coordination and execution of all aspects of pharmacovigilance at the affiliate to ensure that AbbVie’s statutory and ethical responsibilities are met.

Act as the Affiliate’s back-up contact point for pharmacovigilance matters with the National Regulatory Agency and AbbVie Pharmacovigilance and Patient Safety (PPS) 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) back-up in Colombia, 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.
• Maintain an environment of continuous improvement to optimize the affiliate PV system and contribute to regional and global process improvement initiatives, working with PPS subject matter experts.
• Communicate effectively to achieve affiliate/regional/area cross-functional alignment and engagement for a better understanding of the PV strategies and processes to leverage it for success.

Oversight of the Pharmacovigilance System:

• Maintain oversight of affiliate PV compliance status and actively monitor PV workload and resources.
• Escalate compliance issues and potential PV resource issues in a timely manner to the Affiliate Medical Director and International PV Operational Excellence (IPEx) to ensure appropriate mitigation.
• Maintain awareness and monitor local post-marketing and clinical PV legislation, to ensure PV legislation changes are communicated to relevant stakeholders for review, impact assessment, implementation and mitigation according to global procedures.
• Has access to AbbVie’s PV system master file (PSMF) with the authority to ensure that the information contained is an accurate and up-to-date reflection of the PV system in Colombia.

Quality Management System:

• Ensure the Affiliate PV System procedure(s) aligns with corporate PV procedures and complies with local and regional PV regulations.
• Manage any non-conformity and/or planned departures from corporate and/or local PV procedures according to the global issue and exception management process and ensure any corrective/preventive actions are completed according to the schedule.

Adverse Event & Periodic Safety Reporting:

• Ensure that processes, procedures and systems are in place for intake, processing, conducting follow up, translating and reconciling adverse events and other safety information reportable to PPS from spontaneous and solicited sources and from clinical studies.
• Ensure reporting of both clinical and post-marketing Individual Case Safety Reports (ICSRs) and Periodic and Aggregate Reports to the Regulatory Agency, Ethics Committees and Investigators, to comply with corporate PV procedures and with local and regional PV regulations as required.

Audits and Inspections:

• Act as the key Affiliate back-up for both internal PV audits and Regulatory Agency PV inspections.
• Ensure that any audit/inspection responses/corrective actions are completed according to the schedule.
• Support local QA and R&D PV QA to conduct vendor audits and complete vendor corrective action plans.

Risk Management:

• As a member of the Affiliate Risk Management Team (ARMT), review Risk Management Plans (RMPs) and implement risk minimization measures at the affiliate according to AbbVie procedures and local requirements.
• Understand the RMPs and information on the benefit/risk profile of products applicable for the Affiliate.
• Ensure the appropriate development and revision of Local RMPs and/or Country Specific Annexes, if applicable, liaising with ARMT & Benefit Risk Management (BRM) Team during development and revision of local documents.
• Partner with ARMT & Benefit Risk Management (BRM) Team during development or revision of the Local Implementation Plan (LIP) & local additional risk minimization measures.

Safety Monitoring:

• Maintain overview of medicinal product safety profiles and any emerging safety concerns for company products marketed within the relevant jurisdiction, and awareness of conditions or obligations adopted as part of the marketing authorizations, commitments relating to safety or the safe use of the products and of post-authorization safety studies requested by a regulatory agency.
• Understand and monitor incoming local safety data and communicate changes or potential concerns to the PPS Product Safety Team Lead and the EU QPPV (for products marketed in the EEA) for evaluation.
• Ensure a full and prompt response to regulatory agency requests for provision of additional information necessary for the benefit-risk evaluation of a medicinal product.

• AS back-up delegate specific tasks under supervision and with documentation, to appropriately qualified and trained individuals, provided that the QPPV maintains system oversight and overview of the safety profiles of all products in Colombia.

After Hours Availability & Business Continuity:

• Ensure availability to be at AbbVie’s disposal permanently and continuously on a 24-hour basis in Colombia.
• Ensure that an after-hours process is in place for the reporting of AEs.
• Ensure that a Disaster Recovery Plan/Business Continuity Plan is established in a risk-based manner to allow for continuation of critical business processes for PV.

INTERNAL / EXTERNAL CONTACTS AND INTERACTIONS:

• Affiliate medical, regulatory affairs, clinical, quality assurance and customer service personnel.
• Affiliate Marketing, Sales and Operations personnel to ensure that all employees are trained and understand their responsibilities for reporting of any safety information.
• National Regulatory Agency responsible for product safety.
• Pharmacovigilance and Patient Safety, including but not limited to IPEx, Area PV Product Lead, Benefit-Risk Management and QPPV Office.
• Healthcare Practitioners, consumers and patients.

Qualifications

• Medical, pharmacy or life-sciences degree (or equivalent). For Colombia the National QPPV must be Medical or pharmacy degree with knowledge in Pharmacovigilance.
• Minimum of 8 years’ experience working in the pharmaceutical industry in a drug safety role is strongly preferred for the Affiliate Safety Representative role but is less critical for the backup ASR role at least two years’ experience working in the pharmaceutical industry in a pharmacovigilance role is required.
• As Back-up, adequate theoretical knowledge and practical experience of PV activities and system under purview (as stipulated in local guidance) and sound understanding of the regulatory and PV monitoring requirements for assigned territory(ies) that comply with any specific training requirements mandated by relevant regulatory agencies.
• Excellent written and spoken communication and presentation skills.
• Fluency in written and oral English is essential
•  Pharmacovigilance and Patient Safety, Area/Regional Medical and other headquarters functions.
• Fluency in written and oral local language a requirement to facilitate communications within the affiliate medical department, and with the National Regulatory Agency.
• High customer orientation
• Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity
• Sound judgment, strong planning and organizational skills, and the ability to get things done. Demonstrated strong sense of urgency.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html