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
  policy

• Assist 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

• 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.

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.