To help you maintain a balance between work and home obligations, this position offers the fexibility of working 1 day/week from home!
Assure Novartis worldwide PV systems are in a state of global regulatory compliance through internal assessments, consultancy, training and proposals of pragmatic and in-novative solutions to compliance issues.
With minimal or no supervision this individual independently:
1. Serves as a senior contact for PV issues. This includes effectively liaising with busi-ness partners and global colleagues.
2. Works with global Integrated Medical Safety staff to ensure standardization of PV systems and processes; review PV-related procedures.
3. Contributes to developing PV processes across Novartis Pharmacovigilance Units.
4. Independently manages all aspects of PV inspectional activities in close collaboration with CQA and IMS, including fulfilling HA inspection requests, preparing CPO for in-spection, hosting inspections, and preparation of responses
5. Provides expert interpretation of PV regulations, guidelines, policies and procedures, and provides sound guidance to Novartis personnel and contracted service providers, both written and verbal; advisor to management and customers on advanced qual-ity/compliance issues.
6. Conducts PV audits and takes a lead role to evaluate appropriateness of corrective action plans through the evaluation of criticality of issues, risks they pose and com-pleteness to ensure that the issues are adequately addressed and completed. Drive closure of audits through collaboration with Business Partners and CQA Country Management group.
7. Conducts training needs assessment and develops/provides compliance training to CQA and IMS staff in all aspects of quality assurance and safety reporting.
8. Proactively researches local and international PV initiatives, trends and events in or-der to maintain global compliance.
9. Represents CQA in internal and external meetings; organizational spokesperson on PV projects.
10. Applies advanced quality assurance principles and works on unusually complex CQA issues; providing highly innovative and ingenious solutions.
11. Takes the lead in identifying opportunities for process improvements and partici-pates as the key quality/compliance partner on these initiatives
12. Conducts formal investigations of complex compliance issues as they arise. Approximately 10% travel. .
Job Requirements: .
⤠5 + years of pharmacovigilancel/industry/health authority experience. This should include proven understanding of PVG processes;
⤠Ability to manage and objectively evaluate compliance is-sues;
⤠Excellent organizational skills including ability to handle mul-tiple issues on multiple projects simultaneously;
⤠Excellent interpersonal skills, self motivation and positive at-titude
⤠Contribute to global safety initiatives;
⤠Expert in pharmacovigilance and GCP/ICH compliance regu-lations and guidelines, as well as in applicable Novartis SOPs, WP, and NIPs;
⤠Expert knowledge of regulatory guidelines for adverse event reporting;
⤠Maintain a high degree of independence with respect to de-cision making and problem solving;
⤠Able to travel;
⤠Conduct safety audits in accordance with CQA audit pro-gram;
⤠Expert knowledge of FDA regulations, ICH safety guidelines, and GCP;
⤠Knowledge of global safety databases (Argus, SINA);
⤠Ability to teach, mentor and perform job functions;
⤠Ability to operate successfully in various team capacities, in-cluding leader and or active member. .
Applicant Category: Professional
Requisition Code: Work at home
Two Initials of Recruiter: bw
System Date: 05/01/2008
System Time: 15:42:43
Document Name(40): Pharmacovigilance QA Expert
Source: IMDiversity.com - USA
SearchTerms: "work at home" "work from home"
URL(80): http://jobs.imdiversity.com/jobseekerx/ViewJob.asp?JobID=7v4qFxZp2fIs8CXAlxArawp
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