Pharmacovigilance Specialist
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Job Location:
Buenos Aires - Argentina
Monthly Salary:
Not Disclosed
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
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 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
- Establishes standards and oversees the monitoring of outsourced processes investigates and leads the follow-up of discrepancies.
- Leads 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.
- Presents results of quality control 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.
- Leads 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 and reliable documents results
- Proactively leads the identification of areas of process and technical improvement and leads the implementation of changes. Refines and adapts 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 :
- Bachelors Degree or equivalent in related science field
- 4 years pharmaceutical industry experience; including a minimum of 3 years in pharmacovigilance quality systems. Affiliate experience strongly preferred
- Very 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
- Highly skilled in data interrogation and interpretation; highly experienced with using complex models and excel
- Good influencer across multiple stakeholders and manage within an affiliate matrix; seen as a collaborative partner at all levels of the organization
- Proven track record of proactively identify assess and effectively manage compliance risks
- Experienced in working in cross-functional teams or global projects Highly analytical with excellent attention to detail
- Excellent written and spoken English plus highly skilled in at least one other language
Additional Information :
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
- Sales Experience
- Crane
- Customer Service
- Communication skills
- Heavy Equipment Operation
- Microsoft Word
- Case Management
- OSHA
- Team Management
- Catheterization
- Microsoft Outlook Calendar
- EHS
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
