Pharmacovigilance Manager

3 days ago


Johannesburg, South Africa Unique Personnel Full time

**Job Number**
- 67743

**Job Type**
- Permanent

**Job Title**
- Pharmacovigilance Manager

**Computer Skills**
- Oracle,Ms Office

**Industry**
- Manufacture

**City**
- Johannesburg

**Province**
- Gauteng

**Job purpose**
- To provide quality Pharmacovigilance (PV) Management expertise by effectively overseeing all company processes related to drug safety surveillance and response, ensuring compliance with the relevant laws/ regulations and guidelines, as well as internal policies that govern pharmacovigilance practices in each territory where company conducts its business.

**Key Job Outputs**
- Represent company as Qualified Person for Pharmacovigilance in territories as applicable, where company conducts its business.
- Ensure maintenance of quality assured pharmacovigilance systems for marketing authorisation 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 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 internal SOPs Processing of spontaneous adverse drug reactions in Argus or on the safety database, as applicable.**Inherent Requirements**
- 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)

**What Qualification**
- B Pharm Degree with SAPC registration

**Minimum Qualification**
- Bachelors

**Status**
- Available



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