- Job Title Deputy Pharmacovigilance Pharmacist - Half Day
We are hiring a Part-Time Deputy to Pharmacovigilance Head who will support the PV Head in Johannesburg . It is a half day – part time position.
Pharmacovigilance Accountabilities (Deputy to LPVM):
• Assist the local Pharmacovigilance Manager (LPVM) in maintaining a compliant PV system.
• Ensuring the compliance with respective legislation at all times for all relevant countries.
• Implementation of company global and local procedures.
• Assume PV responsibilities for local activities for Clinical Trials (CTs), Investigator Initiated Studies (IIS), Non-Interventional Studies, Compassionate Use Programs / Early Access Programs, Non-Trial Activities and Post Authorization Safety Studies.
• Act as a deputy in the absence of Qualified Person for Pharmacovigilance (LPVM) to local Authorities, whenever required by local regulations
• Ensure local safety data collection and safety reporting, including receipt, processing, distribution, tracking, archiving and follow-up of safety information locally, according to the company procedures and regulations.
• Entering data into respective databases ensuring high accuracy and attention to detail.
• Reporting of relevant individual case safety reports and safety periodic reports to Regulatory Authorities and Ethic Committees, according to local requirements.
• Screening of local literature for adverse event information.
• Review of local customer related screening system results for adverse event information.
• Reconciliation with key partners, e.g. Product Complaints and Medical Information.
• Monitoring and testing of sponsored and company owned websites.
• Handling of regulatory safety requests and any other safety inquiries/issues in close collaboration with local management, ROPU and Regional PV Heads.
• Assist in the reporting and investigation of non-compliances
• Contribute to corrective and preventative action preparation and follow-up processes, whenever applicable
• Assist with Local inspection readiness
• Assist with handling of local PV audits
• Assist with the contribution as appropriate at a local level for implementation and monitoring of risk minimization measures for all products
Minimum Education/Degree Requirements
• Pharmaceutical degree or a suitable medical qualification e.g. nurse, pharmacology degree or some other suable medical /health qualification etc.
Required Capabilities (Skills, Experience, Competencies)
• Minimum 4 years of experience in pharmacovigiliance in the pharmaceutical industry
• Customer approach with high business understanding
• Result orientation and managing ambiguity in difficult situation
• Creativity on finding solutions with ‘can do’ approach
• Setting direction and leading change
• Managing people; attracting and developing talents
• Time management
Send your CV to Vicki at email@example.com