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AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Affiliate PV Partner Compliance Specialist (all genders) - Dutch speaker

Romania Req ID 2207761 Category Medical Division AbbVie

 Our global Pharmacovigilance Team is searching for an

Associate PV Partner Compliance Specialist (All genders) - Dutch speaker

You can be located in Germany, UK, Romania, Netherlands or Belgium

 

Purpose :
Support the establishment and maintenance of effective compliance & oversight of external
providers of pharmacovigilance services for AbbVie affiliates. At a minimum this system must ensure
compliance with global regulatory requirements, AbbVie standards and local PV regulations. The
scope extends to all externalized services and providers overseen by PPS on behalf of AbbVie
affiliates, including adverse event management, reporting, and related operational activities, and
spans all marketed products.

Responsibilities :

  • Manages standards and oversees the monitoring of outsourced processes, investigates and leads
  • the follow-up of discrepancies.
  • Manages the monitoring of supplier performance via SLAs and other metrics, prepares routine and
  • ad hoc reports, leads the investigation of trends, and escalates issues as appropriate.
  • Supports presentations of quality control results and trend analysis to senior, cross-functional
  • AbbVie stakeholders.
  • Support the establishment of AbbVie quality management processes for external suppliers of
  • affiliate pharmacovigilance services that meet applicable PPS, RDQA, and affiliate standards and
  • ensure reproducible, controlled, and timely delivery of high quality outputs.
  • Collaborate with suppliers and internal partners to implement vendor quality management
  • processes which integrate with supplier and AbbVie processes wherever possible. Support the use
  • of risk-proportionate approaches for in-line and retrospective evaluations.
  • Supports development of materials and delivers training sessions (through multiple modalities) in
  • conjunction with supplier, including train-the-trainer, special-topics, refresher, and internal AbbVie
  • trainings as needed.
  • Manages issue investigation (eg CAPAs), coordinating between AbbVie and supplier systems.
  • Supports the communication and collaborates across internal and partner stakeholders for
  • prioritization of issues, as well as timely, effective, and permanent remediation actions.
  • Performs quality control (QC) of all outsourced processes reliable documents results; proactively
  • identifies areas of process and technical improvement and supports the implementation of
  • changes.
  • Proactively suggests changes in QC approaches to account for external and internal process,
  • regulatory and business change.
  • Responsible as a member of the Affiliate PV Operations team for driving compliance and business
  • excellence for all of outsourced affiliate PV activities.


Bachelor’s Degree or equivalent in related science field
3 years pharmaceutical industry experience; including a minimum of 2 years in pharmacovigilance
quality systems. Affiliate experience strongly preferred
Good knowledge of global pharmacovigilance regulations, including one or more countries with an
excellent understanding of PV quality assurance systems
Skilled at technical writing and authoring, including SOPs/procedural documents, corrective actions
plans / exception reports
Good Excel, data interrogation and interpretation skills and experience
Good influencer across multiple stakeholders; seen as a collaborative partner across the
organization
Able to proactively identify, assess, and effectively manage compliance risks
Experienced in working in cross-functional teams
Analytical with a high degree of attention to detail
Very good written and spoken English plus one other language

Key Stakeholders:  PPS: Safety Compliance, Affiliate Vigilance Excellence, Vendor Management
Team, Case Processing Center of Excellence, ODC Center of Excellence, EU QPPV. RDQA:
Pharmacovigilance & Regulatory Affairs Quality Assurance. GMA: Area Medical Heads, Aff MD's

Travel: Yes, 5 % of the Time
Job Type: Experienced
Schedule: Full-time
ABBVIE

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