Senior Pharmacovigilance Director
4 weeks ago
Job Summary
The Senior Pharmacovigilance Director will oversee and implement operations of Pharmacovigilance in North America, ensuring compliance to PV SOPs and generating regional monthly PV reports. This role will also be responsible for ensuring ADE training and/or communication of handling ADEs for non-Drug Safety personnel and reviewing market research surveys received from a pharmacovigilance perspective.
Key Responsibilities
Ensure audit preparedness and manage regulatory and internal inspections
Draft any corrective action/preventative action plans (CAPA) as necessary
Ensure compliance to PV SOPs implemented in North America
Generate the regional monthly PV report
Provide root cause analysis (RCA) and CAPA for North America late reporting as applicable
Ensure procedural deviations are appropriately documented
Qualifications
PharmD, Master's in Pharmaceutical Sciences or MD required
10-12 years' experience in Pharmacovigilance or related field
Supervisory experience required
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