Job summary:

Ready to make an impact on patient safety? Abb Vie is seeking a leader to drive Pharmacovigilance at the affiliate level, reporting to our Medical Director, ensuring our product portfolio meets the highest standards of safety and regulatory compliance. As the key interface between our affiliate, national regulatory agencies, and our Global Patient Safety function, you’ll shape quality systems and champion best practices. In this pivotal role, you’ll independently drive local pharmacovigilance activities as a key individual contributor, ensuring operational excellence and compliance, while also managing one direct report. . If you’re looking to play a key role across our innovative therapeutics and leave no eligible patient behind, this opportunity is for you.

Key responsibilities:

Oversight of the Pharmacovigilance System

• Ensures that PV processes, procedures and systems are in place to comply with Abb Vie Global PV procedures and with local and/or regional PV regulations.
• Maintains oversight of the performance of all activities that fulfil local and applicable regional PV regulations, including those performed by the Regional PV Team and/or outsourced partners and has access to the Abb Vie’s PV System Master File (PSMF).
• Acts as key safety advisor for affiliate cross-functional partners on safety topics

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.
• Maintain 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.
• Oversee training compliance of partner company staff according to local contract requirements.

Adverse Event & Periodic Safety Reporting

• Maintains oversight of the PV system and ensures that processes, procedures and systems are in place for intake, processing, follow up, translation and reconciliation of adverse events and other safety information reportable to GPS from spontaneous and solicited sources as well as from clinical studies.
• Partners with the Regional PV Team in GPS to ensure reporting of both clinical and post-marketing Individual Case Safety Reports (ICSRs) and 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.

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.

Legislation Intelligence

• Collaborates with the GPS Regional PV Teams to ensure monitoring of local (and applicable regional/area) PV-relevant hard intelligence, and leads the impact assessment of such intelligence.

Audits and Inspections

• Serves as the Affiliate Lead and point of contact for affiliate PV audits and Regulatory Authority PV inspections, demonstrating understanding of the overall Abb Vie PV system and how Global PV processes and the GPS Regional PV Teams are set-up and structured, supporting the fulfilment of local legal requirements.

PV Business partnering

• Acts as key safety advisor for affiliate cross-functional partners on safety topics ensuring that business partnerships involving activities where there is a reasonable possibility for the identification and/or handling of safety information are assessed for the generation of safety information and the applicable PV requirements, and that applicable PV and safety data exchange agreements are implemented.

Partners with the GPS Regional PV Team to ensure that:

• All sources of adverse events and other safety information are identified at the local level and mechanisms are in place for collection and collation of all data by GPS.
• Content of local Safety Data Exchange Agreements (SDEAs) and other PV agreements conforms to Abb Vie procedures and local requirements and maintains the inventory in the GPS PV Agreements Database.
• Compliance with local agreements.

PV Training

• Collaborates with the GPS Regional PV Team to ensure overall training compliance with corporate procedures and local PV requirements, including the maintenance of the PV Training Matrix and the development of additional PV training materials, as required.

Risk Management

• Leads the local risk management activities in alignment with local regulations with the Affiliate Medical Director (AMD).
• Coordinates the receipt and distribution of Risk Management Plans (RMPs), Core Implementation Strategy (CIS) and additional risk minimization measures (aRMM) to relevant affiliate stakeholders.

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.
• Be a key driver in the generation and interpret safety evidence across the product lifecycle.
• 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.
• insights/findings with Medical Teams and GPS.
• Leads product safety communication and education initiatives for local cross-functional teams on major PV topics and on local data sources.

PV Advocacy

• Maintains awareness, oversight and actively contributes to assessing the impact of new legislations on the PV system.

• Drives Abb Vie PV advocacy efforts through strong internal and external collaboration including engagement with local trade associations, industry network, and with Regulatory Agencies.

• Collaborates on internal and external PV advocacy efforts, in alignment with the Abb Vie, PSEQ GPS, and QPPV Office advocacy guidance.

• Medical, pharmacy or life-sciences degree (or equivalent).

• At least two years’ experience working in the pharmaceutical industry in a pharmacovigilance role is required, with a scientific acumen and the ability to understand and apply scientific concepts effectively.

• Adequate theoretical knowledge and practical experience of PV activities and systems with sound understanding of the regulatory and PV monitoring requirements in Switzerland

• Excellent written and spoken communication and presentation skills.

• Fluency in English and German, French is advantageous but not required.

• 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.

Abb Vie 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

About Abb Vie

Abb Vie'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 Abb Vie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.