This role will 100% remote
Responsibilities:
- Independently resolves routine issues. Handles complex problems by proposing potential solutions to management. Contributes to departmental policy.
- Review, develops, and monitors global pharmacovigilance compliance metrics.
- Leads the preparation and conduct of PV relevant, internal, and external global audit and inspection process, responses and develops associated improvement plans (e.g., EMA, MHRA, FDA; response to warning letters or USFDA 483s)
- Review and triage of reports of non-conformances and potential non-conformances using professional judgement and expertise
- Review and approve exception reports, planned deviations and CAPA tasks in line with internal and regulatory requirements.
- Review, evaluates and proposes necessary changes to regulatory guidance (e.g., ICH).
- Evaluates and develops appropriate work tools and methodologies to enable staff to continually improve performance and productivity
- Actively identify, propose, and implement improvements while fully engaging in new initiatives to continually support the advancement of the Audit/Inspection process, PV investigation/CAPA process and Planned Deviation process.
Qualifications:
- Bachelor’s degree with related health science background or quality background;
- Minimum 4 years clinical experience or 3 years related pharma experience.
- Must have solid technical and English writing skills to support root cause analysis and CAPA process.
- Must have background supporting Audits, Inspections and Deviation
Job Types: Full-time, Contract
Pay: $25.00 - $30.00 per hour
Expected hours: 40 per week
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Experience level:
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Work setting:
Education:
Experience:
- Quality assurance: 3 years (Preferred)
- Investigations: 3 years (Preferred)
- deviation: 3 years (Preferred)
- CAPA: 3 years (Preferred)
- Root cause analysis: 3 years (Preferred)
- Audit: 3 years (Preferred)
- Pharma or medical device or biotech industry: 3 years (Preferred)
Work Location: Remote