Affiliate Safety Representative

Lead the coordination and of all aspects of pharmacovigilance (PV) at the affiliate to ensure that all of AbbVies statutory and ethical responsibilities are met. Act as the Affiliates main contact point for pharmacovigilance matters with the National Regulatory Agency and AbbVie Pharmacovigilance and Patient Safety (PPS) function. Provides strategic leadership to manage and support the PV team in executing assigned responsibilities. This position reports into the Affiliate Medical Director. For all PVrelated matters this position has additionally a dottedline indirect reporting relationship to the EU QPPV.

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.

Support recruitment onboarding training development through coach and mentoring performance management and succession planning of appropriately skilled PV staff

Oversight of Pharmacovigilance System:

Maintain oversight of affiliate PV compliance status including the compliance status of outsourcing vendor and actively monitor PV workload and resources

Escalate compliance issues and potential PV resource affiliate projects involving activities where there is a reasonable possibility for the identification and/or handling of safety information inclusive of Digital media and internet are assessed for the generation of safety information and the applicable PV requirements are applied in accordance with AbbVie procedures and local requirements.

Safety Data Exchange Agreements (SDEA) and other PV

Agreements:

Ensure the content of local SDEAs and other PV agreements conforms to AbbVie procedures and local requirements and maintains the inventory in the PPS PV Agreements Database.

Maintain and monitor compliance with local agreements.

Audits and Inspections:

Act as the key Affiliate contact 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 postauthorization 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 benefitrisk evaluation of a medicinal product.

After Hours Availability& Business Continuity:

Ensure that an afterhours process is in place for the reporting of AEs.

Ensure that a Disaster Recovery Plan/Business Continuity Plan is established in a riskbased manner to allow for continuation of critical business processes for PV.

Critical Success Factors:

Builds and maintains strong relationships with affiliate colleagues (e.g. Medical Affairs Regulatory Affairs Commercial) and PPS and tailors communication to

different stakeholders to enhance understanding of PV requirements and elevate the PV internal brand

Learns fast grasps the essence ability to manage complexity and changes to change course quickly where indicated to add value to the PV system

Acts consistently with AbbVies ethics obligations and local laws putting patient safety partnerships and overall AbbVies interests before individual immediate team and functional interests

Focused on compliance; identifies manages and escalates issues in a timely manner

Strengthens the use of product safety knowledge and channels scientific safety evidence and benefitrisk information to area and affiliate stakeholders to

positively impact business strategies.

Qualifications :

Medical pharmacy or lifesciences degree (or equivalent).

Minimum of 2 5 yearsexperience working in the pharmaceutical industry in a in a pharmacovigilance role is required and experience in management of direct reports preferred.

Excellent written and spoken communication and presentation skills.

Fluency in written and oral English is essential to facilitate communications with Pharmacovigilance and Patient Safety Area/Regional Medical and other headquarters functions.

Fluency in written and oral local language a requirement in order to facilitate communications within the affiliate medical department and with the

National Regulatory Agency.

High customer orientation

Strong commitment to compliance with the relevant

Additional Information :

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion.  It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.

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

Work :

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