Pharmacovigilance (PV) Audit Manager (P/T Consultant)
Supervise PV activities within MTDA under Senior Director QA.
Manage own workload to ensure appropriate coverage of projects and activities
Provide QA input to MTDA working groups and systems development as appropriate
Provide advice on QA, PV matters to MTDA staff
Liaise with Regulatory Affairs Department in maintaining as awareness of on-going regulatory changes
Participate in internal and external meetings as appropriate
Liaise with relevant parties to arrange the audits as required by audit plans
Perform Internal Process Audits of MTDA processes
Prepare in a timely manner [30 days] reports of audits performed
Distribute relevant audit reports in accordance with MTDA
policyAssist Senior Director of QA, MTDA in providing local US perspective in relation to global activities and systems arising from MTPC
To liaise with QA MTPC & MTPE as required on global programs
Assist Senior Director of QA, MTDA in hosting PV related audits and regulatory inspections of
MTDA activities
Qualifications
- Minimum of a Bachelor's degree in scientific discipline or related field
- Minimum of 5 years of experience as ‘stand-alone’ auditor; i.e. performing audits alone.
- Experience with at least 2 regulatory inspections; at least one of which was an FDA PV Inspection.
- Related professional association membership (e.g., DIA, SQA, etc.)
- Proficiency in common office software (Windows, MS Office Suite)
- Ability to perform CSV audits is an advantage
Willingness to travel approximately 50% both domestically and internationally.
Additional Information
Our Value Proposition:
Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate.