Macleods Hiring Pharmacovigilance Professionals.
Role: PV QA Macleods Pharma LTD
Experience: 4 to 8 years.
Job Role: Individual contributor
Incumbent should have exposure Woking in Pharmacovigilance operations or QMS supporting to PVG operations.
Perform audits to ensure compliance with applicable regulatory guidelines and Standard Operating Procedures and Sponsor’s Specific Requirements.
Develop audit plan and conduct audits of studies, processes, systems and facilities to ensure compliance with applicable regulatory guidelines, Standard Operating Procedures.
Support in establishment of Pharmacovigilance (PV) quality management processes in line with Global policies and local regulations.
Support initiatives focused on PV quality, process and compliance improvement. Plans and conducts Pharmacovigilance system audits in support of global PV activity for post marketed and clinical development products.
Prepare reports and communicate audit findings from audits to auditee.
Follow up all audit reports for completion of corrective actions and ensure timely closure of audit reports.
Plans and conducts system process audits of subsidiaries, vendors, distributors & partners issuing audit reports, suggesting appropriate corrective and preventive action and audit closure
Assisting Pharmacovigilance team to prepare for regulatory inspections.
QMS support to Pharmacovigilance Team
Application Process Contact: firstname.lastname@example.org