Junior Associate Pharmacovigilance Manager (all genders)

Unternehmensbeschreibung

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Stellenbeschreibung

People. Passion. Possibilities. Three words that make a world of difference.

More than a job. It's a chance to make a real difference.

Welcome to AbbVie! As part of an international company with 50,000 employees worldwide and around 3,000 employees in Germany, you will have the opportunity of addressing some of tomorrows unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care? Do you want to contribute to improving patients' quality of life through your expertise? In a challenging work environment that offers opportunities of developing and increasing your own skills? You’ve come to the right place!

As part of the Regional Safety Operations team at the Wiesbaden site, you will be working with talented people and experienced management experts to maintain a high-functioning PV system, enhance our drug safety processes and protect patient well-being.

Your responsibilities:

Metrics and Oversight of the Pharmacovigilance System

• Supports the provision of metrics that will ensure oversight of all aspects of the performance and functioning of the PV system in compliance with local regulations and internal company timelines/standards.

Quality Management System

• Develops and maintains local/regional procedures in line with corporate procedures and local requirements.
• Performs the impact assessment of new/updated corporate policies, process, and procedures.
• Actively assists with the PV Exception Reporting/CAPA process.
• Actively assists with the business continuity plan and testing.
• Develops and maintains the local PSMF in line with AbbVie’s PV system master file, when required by local/regional regulations

ICSR Management

• Records, processes, and conducts follow up and translates adverse events and other safety information from spontaneous and solicited sources.
• Performs ICSR expedited reporting according to the local requirements.
• Ensures local-language medical or scientific literature review.
• Implements an appropriate local quality control (QC) procedure to ensure quality of information entered and reporting decisions.
• Completes AE reconciliation and ensures AE identification effectiveness sampling consistent with global procedures.

Periodic Safety Reporting

• Leads the preparation of periodic safety reports (e.g., PSUR)., local annexes, local variations, and translation of safety deliverable documents.
• Ensures submission of periodic safety reports and ensures documentation of evidence.

Audits and Inspection Management

• Actively assists in managing internal PV audits, audits of affiliate service providers/third parties and Regulatory Authority PV Inspections.
• Actively assists in the development of CAPA in response to observations and the tracking actions to completion in a timely manner.

Partnership with business partner with possibility for identification and/or handling of safety information

• Ensures all PV requirements are in place for activities where there is a reasonable possibility for the identification and/or handling of safety information in accordance with AbbVie procedures and local requirements.

PV Training

• Ensures 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.

Legislation Intelligence

• Monitors local (and applicable regional/area) PV-relevant hard intelligence, leading the impact assessment of them.

Qualifikationen

This is how you can make a difference:

• A minimum of 2 years’ experience required within the pharmacovigilance or a related field
• Effective communicator and able to work effectively in teams and a cross functional environment.
• Strong commitment to compliance with relevant rules and procedures.
• Effective planning and organizational skills, and the ability to complete activities with high quality.
• German and English language skills required, French and Italian language skills preferrable.
  
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  What we offer you:

• a diverse work environment where you can have a real impact
• an open corporate culture
• an attractive salary
• an intensive onboarding process with a mentor at your side
• flexible work models for a healthy work-life balance
• a corporate health management that offers comprehensive health and exercise programs
• company social benefits
• a wide range of career opportunities in an international organization
• top-tier, attractive development opportunities
• a strong international network

Zusätzliche Informationen

AbbVie setzt sich für Chancengleichheit ein und verpflichtet sich, mit Integrität zu arbeiten, Innovationen voranzutreiben, Leben zu verändern und unserer Gemeinschaft zu dienen. Chancengleichheit bei Arbeitgeber/Veteranen/Behinderten.