About this opportunity
Company Description
About AbbVie
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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.
Job Description
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.
Qualifications
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.
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
Job details
How this role compares
Computed from every other active Pharmacovigilance role in our database, not just this employer's listings.
We currently track 159 comparable Pharmacovigilance roles across 54 biopharma companies.
Salary context
33 of 159 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 159 comparable roles
+ 26 more countries
Seniority mix
113 of 159 peers have a known seniority level
Therapeutic area mix
24 of 159 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
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How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.