Pharmacovigilance Lead

Join our team as a Pharmacovigilance Lead and make a meaningful impact on patient safety and regulatory compliance. In this standalone role with a primary focus on Belgium and Luxembourg you will be instrumental in ensuring pharmacovigilance processes align with global and local regulations while maintaining the highest ethical standards. Reporting directly to the Affiliate Medical Director you will serve as the key point of contact for pharmacovigilance matters collaborating with national regulatory authorities and AbbVies Pharmacovigilance and Patient Safety Epidemiology and Research & Development Quality Assurance (PSEQ) function to uphold excellence in safety and compliance.

At AbbVie patient safety is at the heart of everything we do. Through safety science we have evolved into a true crossfunctional partner demonstrating the added value PV brings to healthcare and innovation.

A career in PV at AbbVie offers unparalleled opportunities to work with bestinclass innovative products throughout their entire life cyclefrom prelaunch phases to wellestablished treatments like Humiraacross multiple therapeutic areas. This dynamic environment presents unique challenges and opportunities for affiliate safety representatives to contribute to business success through safety science.

Moreover with the recent and ongoing implementation of our new PV structure the affiliate safety representative will have the chance to actively shape their role within a mature PV organization benefiting from a highly accessible peer network and welldeveloped support and onboarding tools.

Major Responsibilities :

• Pharmacovigilance Oversight: Ensure systems and procedures comply with global and regional regulations maintaining oversight on safety activities and processes.
• Quality Management: Align local procedures with corporate standards manage corrective actions and oversee training compliance of staff.
• Safety Science: Oversee the PV system to ensure the accurate reporting and processing of adverse events coordinating with regional teams. Maintain an overview of product safety profiles and emerging safety concerns communicating relevant information to the appropriate teams.
• Risk Management: Lead risk management processes ensuring proactive identification and implementation of mitigation strategies.
• Adverse Event Management: Oversee intake processing and reporting of adverse events and periodic safety updates to authorities.
• Audits and Inspections: Act as the primary contact for audits and inspections while supporting corrective actions.
• Advocacy and Legislation: Stay informed on new regulations and drive internal and external advocacy efforts.

Qualifications :

• Medical pharmacy or lifesciences degree (or equivalent).
• At least two years experience working in the pharmaceutical industry in a pharmacovigilance role is required.
• Excellent written and spoken communication and presentation skills.
• Fluency in written and oral English is essential to facilitate communications with PSEQ Area/Regional Medical and other headquarters functions.
• Fluency in written and oral French & Dutch is 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 :

At AbbVie we care deeply about bringing innovative solutions to patients in need. By joining us as a Product Specialist youll be at the forefront of our mission working in a dynamic and supportive environment that encourages growth and collaboration.

• All4OneAbbVie: Foster strong interpersonal relationships and teamwork.
• Decide Smart & Sure: Navigate ambiguity and make informed decisions.
• Agile & Accountable: Communicate a clear and inspiring vision.
• Clear & Courageous: Provide honest and constructive feedback.
• Make Possibilities Real: Efficiently plan and execute tasks while adapting to challenges.

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

Work :

No