Senior Affiliate PV Partner Compliance Specialist
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Reporting to our Associate Director Global Safety Operations you will support the establishment and maintenance of effective compliance and oversight for external providers of pharmacovigilance (PV) services for AbbVie addition you ensure all activities meet global regulatory standards AbbVie policies and local PV regulations. You will oversee outsourced services and vendors including adverse event management reporting and related processes for all marketed products.
Key Responsibilities:
- Establish and monitor standards for outsourced PV activities; investigate and lead follow-ups on process discrepancies
- Lead monitoring of supplier performance analyze SLAs and metrics; prepare routine/ad hoc reports and investigate trends escalating issues as needed
- Present quality control and trend analysis to senior cross-functional stakeholders
- Support and implement AbbVie quality management systems for external PV suppliers ensuring consistent delivery of high-quality outputs
- Collaborate with suppliers and internal teams to integrate vendor quality management processes
- Develop and deliver compliance training including train-the-trainer and refresher sessions as well as internal and external education
- Lead investigation of CAPAs and coordinate issue resolution and remediation actions across stakeholders
- Perform document and improve quality control on outsourced processes
- Proactively drive improvements in compliance and QC approaches adapting to regulatory and business changes
- Play an active role within the Affiliate PV Operations team to drive compliance and business excellence in all outsourced affiliate PV activities
Qualifications :
We are seeking a person who has the following skills and experience:
- Bachelors Degree (or equivalent) in a science-related field (required)
- Minimum 4 years pharmaceutical industry experience or including at least 3 years in pharmacovigilance quality systems; alternatively experience in a pharmacovigilance position in a CRO
- Affiliate PV experience desirable
- Very good knowledge of global pharmacovigilance regulations and PV quality assurance systems
- Skilled technical writer with experience in SOPs procedural documents CAPAs/exception reports
- High-level skills in data interrogation analysis and advanced Excel use
- Excellent influencing and communication skills able to manage stakeholders and collaborate in a matrix/global environment
- Strong track record of proactive compliance risk management
- Highly analytical with meticulous attention to detail
- Fluent in English and Spanish; proficiency in at least one additional language is highly valued (preferred; French German Dutch Portuguese advantageous)
Additional Information :
Joining AbbVie means you will be part of a team of outstanding professionals dedicated to making a remarkable impact on patients lives. At AbbVie we conduct ground-breaking science on a global scale every day.
This is a hybrid position with ideal location Bucharest however we are open to consider applicants from other locations.
To apply for this position please submit a CV at your earliest convenience. Applications will close on the 4.12.25.
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:
No
Employment Type :
Full-time
Key Skills
- Compliance Management
- Risk Management
- Financial Services
- PCI
- Banking
- Cost Accounting Standards
- Quality Systems
- Research Experience
- NIST Standards
- Securities Law
- SOX
- ISO 27000
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
