Pharmacovigilance Officer - - Centurion

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
Computer literate with good knowledge of MS applications.
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
Excellent analytical thinking, with the ability to evaluate and present complex safety data applying sound judgement.

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 and inspections.
Support the Safety Evaluation and Risk Management (SERM) team with aggregate PV data analysis for signal detection/ aggregate reporting purposes.
Act as a Local Qualified Person for Pharmacovigilance (LQPPV)
Provide input and support into periodic client activity reports.

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Pharmacovigilance Officer - Centurion

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