Must Have
- B Pharm Degree with SAPC registration
- Minimum 5 Years Pharmacovigilance Experience
- At least 5 years pharmaceutical industry experience in Multinational Pharma
- Computer Literacy: MS Office (Oracle experience would be an advantage)
- Represent Company as Qualified Person for Pharmacovigilance in territories as applicable, where it conducts its business.
- Ensure maintenance of quality assured pharmacovigilance systems for marketing authorization holders, and responsible for the maintenance of the Pharmacovigilance System Master file.
- Manage GVP team and ensure effective operational implementation of internal policies that govern pharmacovigilance practices.
- Mentor and provide / coordinate training and coaching in related GVP topics.
- Monitor KPIs in GVP areas and propose remedial and improvement priorities and actions.
- Ensure the GVP principles are run in accordance with Health Authority regulations in all territories in which the Company actively markets product.
- Responsible for contract negotiation with all local and international partners and ensure compliance to all aspects of the SDEA.
- Establishing and maintaining business continuity plans in GVP department
- Identify trends and agree the areas of compliance risk and follow-up of any issues. Responsible for submission of Risk Management plans where applicable and tracking closure of action items.
- Manage all aspects of PV training for Company staff and vendors in line with Company`s SOPs Processing of spontaneous adverse drug reactions in Argus or on the safety database, as applicable.
- Pharmacovigilance
- SDEA
- Risk Management
- Standard Benefits
