Clinical Affairs Specialist - 008/2020
Code/Reference:
008/2020
Applications accepted until:
2020-02-27
Number of Openings
1

Employment Type

Full time

Department

Regulatory and Clinical Affairs

Minimum 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

Additional Requirements

  • 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
    • Ensure clear understanding of and the effective provision of the clinical and product information requirements of NBI departments and external customers.
    • Provide an up-to-date, objective and accurate medicines information service to ensure appropriate use of NBI€™s products within the clinical settings in which they are used.
    • Compile, review and update clinical and product information in promotional items, professional information (PIs) and patient information leaflets (PILs).
    • Monitor the procedures, systems, databases and documentation appropriate to record, track and report on enquiries.
  • Post Marketing Studies and Clinical Trials
    • Assist with NBI regulatory requirements for post marketing surveillance studies and clinical risk management / minimisation activities.
    • 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
    • Ensure the company Pharmacovigilance Programme is efficient and effective in compliance with relevant statutory requirements and in accordance with national and international guidelines.
    • 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.
    • Oversee the procedures and documentation to appropriately record, track and report on product complaints.
  • Clinical education and training
    • Deliver effective undergraduate, postgraduate and CME training programmes relating to products
    • 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
    • Supervise appropriate access to and retrieval of current clinical and product information to meet department objectives.
    • Manage the library services and medication information resources effectively and efficiently.
    • Ensure the information acquisition and dissemination is systematic, organised and traceable for strategic and operational benefit.
  • Performance management of staff
    • Provide managerial support, guidance and oversight to operate at an optimal performance level.

Competencies

  • 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
  • Communication
  • Initiative
  • Self-management
  • Interpersonal skills