Pharmacovigilance Manager

**Reporting to Head**: Medical Affairs

Job Purpose

To provide quality Pharmacovigilance (PV) Management expertise by effectively overseeing all The Client 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 the Client conducts its business.

Required Learning

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)

QA Key Job Outputs

Represent The Client as Qualified Person for Pharmacovigilance in territories as applicable, where The Client 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 The Client 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 The Clients staff and vendors in line with The Clients internal SOPs Processing of spontaneous adverse drug reactions in Argus or on the safety database, as applicable.

Core Competencies

Decisiveness and Action Orientation;
Attention to detail and accuracy;
Ability to handle pressure;
Self-motivated;
Good communication skills;
Good time management;
Strategic Thinking, Planning and Organising;
Supportive orientation;
Developing people;
Ethical responsibility;
Cross Functional Capability;
Presentation skills