Pharmacovigilance Specialist maternity replacement
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Job Location:
Monthly Salary:
Posted on:
13 hours ago
Vacancies:
1 Vacancy
Job Summary
This position is accountable for executing the day-to-day operations and compliance activities to maintain high functioning PV systems across assigned region.
Metrics and Oversight of the Pharmacovigilance System
- Supports the provision of metrics that will ensure oversight of all aspects of the performance and functioning of the PV system in compliance with local regulations and internal company timelines/standards.
Quality Management System
- Develops and maintains local/regional procedures in line with corporate procedures and local requirements.
- Performs the impact assessment of new/updated corporate policies process and procedures.
- Actively assists with the PV Exception Reporting/CAPA process.
- Actively assists with the business continuity plan and testing.
- Develops and maintains the local PSMF in line with AbbVies PV system master file when required by local/regional regulations.
ICSR Management
- Records processes and conducts follow up and translates adverse events and other safety information from spontaneous and solicited sources.
- Performs ICSR expedited reporting according to the local requirements.
- Ensures local-language medical or scientific literature review.
- Implements an appropriate local quality control (QC) procedure to ensure quality of information entered and reporting decisions.
- Completes AE reconciliation and ensures AE identification effectiveness sampling consistent with global procedures.
Periodic Safety Reporting
- Leads the preparation of periodic safety reports (e.g. PSUR). local annexes local variations and translation of safety deliverable documents.
- Ensures submission of periodic safety reports and ensures documentation of evidence.
Audits and Inspection Management
- Actively assists in managing internal PV audits audits of affiliate service providers/third parties and Regulatory Authority PV Inspections.
- Actively assists in the development of CAPA in response to observations and the tracking actions to completion in a timely manner.
Partnership with business partner with possibility for identification and/or handling of safety
information
- Ensures all PV requirements are in place for activities where there is a reasonable possibility for the identification and/or handling of safety information in accordance with AbbVie procedures and local requirements.
PV Training
- Ensures overall training compliance with corporate procedures and local PV requirements including the maintenance of the PV Training Matrix and the development of additional PV training materials as required.
Qualifications :
- 1 year experience required within the pharmacovigilance or a related field
- Effective communicator and able to work effectively in teams and a cross functional environment.
- Strong commitment to compliance with relevant rules and procedures.
- Effective planning and organizational skills and 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 :
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
