VACANCY: CLINICAL AFFAIRS SPECIALIST
Division / Department: Manager: Regulatory & Clinical Affairs
Position reports to: Quality Management and Scientific Affairs
About the role
Provision of a reliable and efficient clinical affairs and information service that puts current knowledge and experience of clinical related aspects of plasma derived medicinal products to work, in supporting the business and operational goals of The Client, as well as compliance with regulatory requirements.
• B Sc. (Pharm) or B Pharm
• Registered Pharmacist (SAPC)
• Postgraduate clinical pharmacy/related degree or studies
• 3 years’ experience in a Clinical Pharmacy/Medicines Information
• 2 years’ experience with Clinical trials
• 2 years’ experience in Pharmacovigilance
• 2 years’ Managerial experience
• Computer Literacy (MS Office: Word, Excel, PowerPoint & Outlook)
• Thorough knowledge of Bibliographic management software
• Previously worked with databases (MS Access, Lotus Notes, or similar)
• Literature searching & evaluation skills
• Training/Lecturing Skills would be an advantage
Specific Operational Requirements
• The successful candidate will be required to work an 8 hour day between 08h00 to 16h00
• The successful candidate may be required to work overtime to meet the business needs
• Local travel may be required to meet business needs
Key Performance Areas
• Clinical and Product Information
o Ensure clear understanding of and the effective provision of the clinical and product information requirements of The Client departments and external customers.
o Provide an up-to-date, objective and accurate medicines information service to ensure appropriate use of The Client’s products within the clinical settings in which they are used.
o Compile, review and update clinical and product information in promotional items, professional information (PIs) and patient information leaflets (PILs).
o Monitor the procedures, systems, databases and documentation appropriate to record, track and report on enquiries.
• Post Marketing Studies and Clinical Trials
o Assist with The Clients regulatory requirements for post marketing surveillance studies and clinical risk management / minimisation activities.
o Facilitate the planning, monitoring and delivery of a well-organised post marketing study or clinical trial in compliance with current guidelines and regulatory requirements.
• Pharmacovigilance and Product Complaints
o Ensure the company Pharmacovigilance Programme is efficient and effective in compliance with relevant statutory requirements and in accordance with national and international guidelines.
o Prepare clinical risk management reports, risk-benefit assessments; periodic safety update and summary reports and amendments to safety statements in PIs and PILs to meet regulatory requirements.
o Oversee the procedures and documentation to appropriately record, track and report on product complaints.
• Clinical education and training
o Deliver effective undergraduate, postgraduate and CME training programmes relating to products
o Conduct Continuing Medical Education (CME) for internal and external stakeholders and healthcare professionals in the various fields including of immunology, haematology, clinical pharmacology and pharmacovigilance.
• Information resource management
o Supervise appropriate access to and retrieval of current clinical and product information to meet department objectives.
o Manage the library services and medication information resources effectively and efficiently.
o Ensure the information acquisition and dissemination is systematic, organised and traceable for strategic and operational benefit.
• Performance management of staff
o Provide managerial support, guidance and oversight to operate at an optimal performance level.
• Technical/professional knowledge & skills
• Attention to detail and thoroughness
• Managing work, planning and organising
• Fact finding
• Analysis/Problem assessment (Logical/analytical)
• Customer Focus
• Collaboration and teamwork
• Interpersonal skills