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Affiliate PV Partner Compliance Specialist
hace 4 meses
Company Description
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 Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
- Reporting to Associate Director, Medical Safety Surveillance.
- Homebased role available in UK, Spain or US.
- Comprehensive salary, bonus and benefits package.
Role overview:
The Affiliate PV Partner Compliance Specialist supports 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 Pharmacovigilance and Patient Safety (PPS) on behalf of AbbVie affiliates, including adverse event management, reporting, and related operational activities, and spans all marketed products.
Key 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 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 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.
Qualifications
Qualifications and Experience:
- Bachelor's Degree or equivalent, in a scientific field.
- Experience working within Pharmacovigilance in the pharmaceutical industry, including experience with PV quality systems. Affiliate experience preferred.
- Must have fluent Spanish and English, written and verbal, language skills.
- Good knowledge of global pharmacovigilance regulations in one or more countries.
- 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 influencing skills across multiple stakeholders; seen as a collaborative partner across the organization.
- Able to proactively identify, assess, and effectively manage compliance risks.
- Experience working in cross-functional teams.
- Analytical, with a high degree of attention to detail.
Additional Information
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie'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.
