Pharmacovigilance Manager
Job Description
<p><strong>Purpose of the Role</strong></p><p>The Pharmacovigilance Manager is responsible for the development, implementation and continuous improvement of a Pharmacovigilance system that includes the full scope of processes and activities performed by NewBridge Pharmaceuticals, our Partners, Affiliates, Service Providers, etc.</p><p>The Pharmacovigilance Manager is the key point of contact for PV at NewBridge and shall act as the QPPV for internal and external stakeholders and shall work closely with all functions and franchises to implement strategic initiatives and ensure consistency throughout the Region.</p><p><br></p><p><strong>Required Competencies, Qualifications and Experience</strong></p><p><strong>路 </strong> Graduate, with at least a BSc in Pharmacy </p><p>路 Minimum of 4 years of experience in PV in a MNC Pharmaceutical in the region is required</p><p>路 Experience working across the NAF region is preferred </p><p>路 Fluent in English</p><p><br></p><p><strong>Responsibilities & Accountabilities</strong></p><p><strong>路 </strong> Lead Pharmacovigilance (PV) activities for NewBridge Pharmaceuticals, and act as point of contact for all PV related matters</p><p>路 Develop, implement and review of PV Policies, SOPs and Working Practices </p><p>路 Initiate and ensure that Safety Data Exchange Agreements (SDEAs) with business partners, local distributors and vendors are in place and ensure compliance with the SDEAs</p><p>路 Maintain highest level of awareness, expertise in international and local country PV regulations and NewBridge internal policies and SOPs, and assess impact of new regulations and guidance on PV activities</p><p><strong>路 </strong>Ensure training of all NewBridge employees and third-party staff on PV reporting requirements, and conduct annual training updates</p><p><strong>路 </strong>Establish strong partnerships with key stakeholders in internal functions and represent PV with partners, customers and stakeholders on PV related issues</p><p>路 Define and design audit scope/program for both internal functions and partners, etc. and ensure the program is in line with risk of PV processes and activities</p><p>路 Conduct annual PV audits as per program, and assist evaluation of CAPA as assigned, and support regulatory authority PV inspections as necessary</p><p>路 Assess data/metrics from PV audits, inspections, regulatory intelligence and risk management activities by the business functions for compliance trends and risks; and communicate to relevant parties</p><p>路 Maintain awareness of changes to regulatory guidance documents, requirements and state-or-the-art pharmacovigilance processes and make recommendations leading to the improvement of the effectiveness </p><p>路 Monitor Adverse Events mailbox and telephone reporting lines as per the set frequency</p><p>路 Report Adverse Events (AE) to all internal and external stakeholders </p><p>路 Maintain regulatory compliance by ensuring that PV tasks are performed within specified timelines</p><p>路 Complete AE reporting tools and tracking reports</p><p>路 Follow up report submission (within set limits)</p><p>路 Work closely with QA manager ensuring PV alignment with QMS.</p><p></p>
