- Job Title Deputy Pharmacovigilance Manager - Pharmaceuticals
A Global pharmaceutical company has an opportunity for a half-day pharmacovigilance pharmacist with 4 years experience.
We are hiring a Deputy to Pharmacovigilance Head who will support the PV Head in Johannesburg . It is a half day – permanent position.
Pharmacovigilance Accountabilities (Deguty 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 (11S), Non-lnt e rventional 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
The relevant laws and principles associated with Employment Equity will be considered when appointing potential candidates.
Email your CV to firstname.lastname@example.org