Pharmacovigilance Officer

Our client, a rapidly growing global specialty pharmaceutical and services company based in Centurion Irene is searching for Pharmacovigilance Officer to join their team.

**Requirements**:

- Healthcare Professional qualification or equivalent of a Bachelor of Science (BSc) degree.
- Proven and demonstrable experience in PV.
- Evidence of being able to build relationships with key internal and external customers and demonstrate customer focus.
- Attention and the ability to work effectively in an environment characterised by tight timeliness and changing priorities.
- Excellent organizational and prioritization skills and strong analytical skills and problem-solving skills.
- Excellent oral and written communication skills.
- Ability to build relationships with key internal and external customers.
- Excellent attention to detail and ability to work under pressure
- Outstanding written, verbal, and interpersonal communication skills
- Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment
- Proven ability to work collaboratively within a matrix and/or cross-functional environment
- Self-motivated and organised, with the ability to work unsupervised for periods of time

**Key internal responsibilities**:

- Working within the international Pharmacovigilance Operations Team.
- Experience and qualified to perform quality control of other PV Operations activities.
- Provide oversight and support to the Operational Team from processing safety information and forwarding it to the client/third-party vendor within stipulated timelines.
- Maintain oversight of reconciliation activities with internal departments/clients/ third parties within the agreed timelines.
- Ensure all internal/ external queries received via PV mailbox are tracked as well as professionally and efficiently responded to within stipulated timelines.
- Responsible for investigating late adverse events and deviations, followed by developing and implementing appropriate corrective and preventative actions (if necessary) on time within the Quality Management System.
- Responsible for the collection of Key Performance Indicators (KPI) and providing input in the monthly compliance report.
- Improve and enhance internal processes to increase efficiency and develop departmental tools to ensure compliant completion of delegated client services as required.
- Actively participate in the preparation of client/third-party/ vendor audits.
- Provide backup support with PV Operational Management activities, as and when required.
- Support quality and efficiency strategies within the organization.
- Support the Company by attending BID defense meetings.
- Provide Senior Management with regular updates regarding the status of specific project/ Client activities.
- Developing PV medical training presentations and delivering training, as required.
- Assisting in departmental regulatory inspection preparedness for the company pharmacovigilance system and actively participating the PV inspections or audits.
- Contributes to improvements of team processes.
- Other PV operational activities or initiatives as assigned.
- Maintaining good client relations and ensuring a consistently high quality of work for each client.
- Mentoring and training of new PV Operational staff.
- Responsible for relevant SOP authoring/ updating, ensuring all contractual requirements with regards to Pharmacovigilance are updated in the relevant procedures, and contribute to and ensure system improvement.
- May be required to line manage PV Associates/ Senior PVC Associates.

Key responsibilities for Clients
- Ensure all internal/external queries are tracked/ professionally and efficiently responded to within the stipulated time.
- Oversee Case regulatory reporting.
- Investigating cases of non-compliance of SAEs/ICSRs and supporting the development of non-conformances and corrective and preventative actions.
- Provide PV Operations input into the preparation and set-up of new client projects/products, ensuring procedures and SMPs/COGs are accurate and effective to ensure compliance.
- Literature search string formulation and sensitivity testing.
- Assist with case processing workflow when needed to ensure due dates are met.
- Ensure all regulatory reporting is performed in full compliance with regulations and applicable ICH/GCP guidelines.
- Assist with the resolution of any identified non-conformances.
- Ensure monitoring of compliance metrics is performed as required and timelines are being met for expedited reporting.
- Communicating with Clients and/or Partners regarding the evaluation and processing of ICSRs.
- Performing quality control of cases in the Global Drug Safety database.
- Expedited Reporting activities involving Work Instruction Updates, System Reporting Rules, Regulatory Intelligence, and Clinical Reporting Instructions Updates.
- Assists when required in Partner, Health Authority Audits/ Inspections.
- Participation in Client audits an