Affiliate PV Partner Compliance Specialist Lisboa

Affiliate PV Partner Compliance Specialist
Lisboa
Lisboa, Lisboa, Portugal

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about Abb
Vie, please visit us atwww.abbvie.com. Follow @abbvie onTwitter, Facebook, Instagram, You
TubeandLinked
In.

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

Main responsibilities:

1. Manages standards and oversees the monitoring of outsourced processes, investigates and leads the
   - up of discrepancies.
2. 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.
3. Supports presentations of quality control results and trend analysis to senior,
   - functional Abb
   Vie stakeholders.
4. Support the establishment of Abb
   Vie 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.
5. Collaborate with suppliers and internal partners to implement vendor quality management processes which integrate with supplier and Abb
   Vie processes wherever possible.
6. Support the use of
   - proportionate approaches for
   - line and retrospective evaluations.
7. Supports development of materials and delivers training sessions (through multiple modalities) in conjunction with supplier, including
   -
   - trainer,
   - topics, refresher, and internal Abb
   Vie trainings as needed.
8. Manages issue investigation (eg CAPAs), coordinating between Abb
   Vie 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.
9. 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.
10. Proactively suggests changes in QC approaches to account for external and internal process, regulatory and business change.
11. Responsible as a member of the Affiliate PV Operations team for driving compliance and business excellence for all of outsourced affiliate PV activities.

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

Abb
Vie 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 Abb
Vie’s 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.

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