PV Operational Associate
PV Operational Associate
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Purpose:
This position is accountable for executing the daytoday operations and compliance activities to maintain highfunctioning PV systems across the assigned region remit. It reports directly to the PV Operational Team Lead.
Responsibilities:
- Metrics and Oversight of the Pharmacovigilance System: Support the provision of metrics to ensure oversight of PV system performance and compliance.
- Quality Management System: Develop and maintain local/regional procedures in line with corporate and local requirements. Perform impact assessments of new/updated corporate policies. Assist with the PV Exception Reporting/CAPA process business continuity plan and local PSMF development.
- ICSR Management: Record process conduct followup and translate adverse events. Ensure locallanguage literature review and implement local QC procedures. Complete AE reconciliation consistent with global procedures.
- Periodic Safety Reporting: Lead preparation and ensure submission of clinical periodic safety reports.
- Audits and Inspection Management: Assist in managing internal PV audits audits of affiliates and regulatory inspections. Develop CAPA in response to observations.
- Partnership with Business Partner: Ensure PV requirements are in place for safety information handling.
- PV Training: Ensure training compliance with corporate and local PV requirements.
- Legislation Intelligence: Monitor and assess local PVrelevant hard intelligence.
- After Hours Availability & Business Continuity: Ensure 24hour availability for AE reporting and have a Disaster Recovery Plan.
Qualifications :
Qualifications:
- A minimum of 3 years of experience required within pharmacovigilance or a related field.
- Effective communicator able to work in teams and a crossfunctional environment.
- Strong commitment to compliance with relevant rules and procedures.
- Effective planning and organizational skills with the ability to complete activities with high quality.
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 :
Fulltime
Employment Type
Full-time
