Pharmacovigilance T05

About AbbVie

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RESPONSIBILITIES:

Acts as the Affiliate’s main contact point for pharmacovigilance PV matters with the National Regulatory Agency and AbbVie Global Patient Safety (GPS).

Periodic Safety Reporting:

• Partners with the Regional PV Team in GPS to support Periodic and Aggregate Reports to the Regulatory Agencies, Ethics Committees and Investigators, in compliance with corporate PV procedures and with local and regional PV regulations as required.
• Cooperation with local RA team to prepare License renewal PSUR and local Annex to support  application submission to HA.

Audits and Inspections:

• Act as the key contact for Affiliate PV audits and Regulatory Authority PV inspections.
• Support and ensure that any audit/inspection responses/corrective actions are completed according to the schedule.
• Support to collaborate with the GPS Regional PV Team audits as well as of affiliate service providers and third parties.

Risk Management:

• Ensure local risk management activities in alignment with local regulations.
• Coordinates the receipt and distribution of Risk Management Plans (RMPs), Core Implementation Strategy (CIS) and additional risk minimization measures (aRMM) to relevant affiliate stakeholders.
• Understand the RMP to obtain information on the risk/benefit profile of products.
• Liaises with the affiliate stakeholders and the Office of Risk Management and where applicable, seek involvement of relevant global stakeholders during development or revision of the local RMP or RMP Annex (if applicable), Local Implementation Plan (LIP) & local or country-specific aRMM.
• Performs the assessment and implementation of the CIS and accompanying aRMM, when applicable.

Safety Monitoring and Evidence Generation:

• Maintains an overview of medicinal product safety profiles and any emerging safety concerns for company products marketed within the relevant jurisdiction, and maintains 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.
• Understands and monitors incoming local safety data and communicate changes or potential concerns to the GPS Product Safety Team Lead and the EU QPPV (for products marketed in the EEA) for evaluation.
• Through monitoring of safety data, the ASR back up ensures that robust evidence is generated to inform risk management, regulatory submissions, and product safety profiles.
• Reviews summary reports of local research-related activities and communicates any safety insights/findings with Medical Teams and GPS.
• As a member of product safety communication and education initiatives for local cross-functional teams on major PV topics and on local data sources.

Quality Management System:

• Partners with the Regional PV Teams to:
  • Ensure 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.
  • Support oversight of the PV training plan and ensure training compliance of local PV personnel and other affiliate personnel with Corporate and Local PV training requirements.

Launch Readiness:

• Sets a solid local safety and PV strategy incorporating proactive PV contributions to ensure a successful product or indication launch at the affiliate.
• Acts as key safety advisor for affiliate cross-functional partners on safety topics.

INTERNAL/EXTERNAL CONTACTS AND INTERACTIONS:

• Affiliate Medical, Regulatory Affairs, Clinical, Quality Assurance and Customer Service personnel.
• Functions that are more likely to become aware of or receive safety information (e.g. Affiliate Marketing, Sales and Operations personnel), to ensure that all employees are trained and understand their responsibilities for reporting of any safety information.
• Affiliate Patient Experience, Customer Excellence and General Manager
• National Regulatory Agency responsible for product safety.
• Global Patient Safety (GPS) including but not limited to the Regional PV Team, Area PV Product Lead, QPPV Office and Risk Management Teams.
• Healthcare Practitioners, consumers and patients.

RESPONSIBILITIES:

Acts as the Affiliate’s main contact point for pharmacovigilance PV matters with the National Regulatory Agency and AbbVie Global Patient Safety (GPS).

Periodic Safety Reporting:

• Partners with the Regional PV Team in GPS to support Periodic and Aggregate Reports to the Regulatory Agencies, Ethics Committees and Investigators, in compliance with corporate PV procedures and with local and regional PV regulations as required.
• Cooperation with local RA team to prepare License renewal PSUR and local Annex to support  application submission to HA.

Audits and Inspections:

• Act as the key contact for Affiliate PV audits and Regulatory Authority PV inspections.
• Support and ensure that any audit/inspection responses/corrective actions are completed according to the schedule.
• Support to collaborate with the GPS Regional PV Team audits as well as of affiliate service providers and third parties.

Risk Management:

• Ensure local risk management activities in alignment with local regulations.
• Coordinates the receipt and distribution of Risk Management Plans (RMPs), Core Implementation Strategy (CIS) and additional risk minimization measures (aRMM) to relevant affiliate stakeholders.
• Understand the RMP to obtain information on the risk/benefit profile of products.
• Liaises with the affiliate stakeholders and the Office of Risk Management and where applicable, seek involvement of relevant global stakeholders during development or revision of the local RMP or RMP Annex (if applicable), Local Implementation Plan (LIP) & local or country-specific aRMM.
• Performs the assessment and implementation of the CIS and accompanying aRMM, when applicable.

Safety Monitoring and Evidence Generation:

• Maintains an overview of medicinal product safety profiles and any emerging safety concerns for company products marketed within the relevant jurisdiction, and maintains 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.
• Understands and monitors incoming local safety data and communicate changes or potential concerns to the GPS Product Safety Team Lead and the EU QPPV (for products marketed in the EEA) for evaluation.
• Through monitoring of safety data, the ASR back up ensures that robust evidence is generated to inform risk management, regulatory submissions, and product safety profiles.
• Reviews summary reports of local research-related activities and communicates any safety insights/findings with Medical Teams and GPS.
• As a member of product safety communication and education initiatives for local cross-functional teams on major PV topics and on local data sources.

Quality Management System:

• Partners with the Regional PV Teams to:
  • Ensure 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.
  • Support oversight of the PV training plan and ensure training compliance of local PV personnel and other affiliate personnel with Corporate and Local PV training requirements.

Launch Readiness:

• Sets a solid local safety and PV strategy incorporating proactive PV contributions to ensure a successful product or indication launch at the affiliate.
• Acts as key safety advisor for affiliate cross-functional partners on safety topics.

INTERNAL/EXTERNAL CONTACTS AND INTERACTIONS:

• Affiliate Medical, Regulatory Affairs, Clinical, Quality Assurance and Customer Service personnel.
• Functions that are more likely to become aware of or receive safety information (e.g. Affiliate Marketing, Sales and Operations personnel), to ensure that all employees are trained and understand their responsibilities for reporting of any safety information.
• Affiliate Patient Experience, Customer Excellence and General Manager
• National Regulatory Agency responsible for product safety.
• Global Patient Safety (GPS) including but not limited to the Regional PV Team, Area PV Product Lead, QPPV Office and Risk Management Teams.
• Healthcare Practitioners, consumers and patients.

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