Medical Information Pharmacist – Woodmead

MAIN DUTIES

MEDICAL INFORMATION (MI)

Responsible for:

• Providing support within the MI function in responding to labelled medical information enquiries for Aspen and contractual partners.
• The provision of compliant responses to internal and external customers.
• The creation and maintenance of a standard responses (SRs).
• Quality control activities for labelled responses and identification of adverse events (AEs), product quality complaints (PQCs) and potential counterfeit medicines.
• Ensuring that Affiliate/Distributor/MI is adhering with Aspen’s Policy in providing scientific support to internal and external customers.
• Identify gaps and suggest ways of process improvement in MI.
• Ensuring that the relevant department is informed in a timely manner following the receipt of adverse event or product quality complaint reports within the MI function.
• Ensuring that the reconciliation between Medical Information function and Pharmacovigilance and Quality department is effective by performing ad hoc reviews on reconciliation files.
• Ensuring that any suggested improvements within the professional information and/or patient information leaflets are communicated to the PV manager at the point of identification.
• Supporting the line manager in generation of medical information reports showing trends in medical information enquiries received.
• Ensuring telephony system testing documents are signed off as specified in the relevant procedural documents.
• Ensuring a professional attitude is displayed when responding to a customer’s needs.

SCIENTIFIC MATERIAL REVIEW AND COMPLIANCE MONITORING

Responsible for:

• Reviewing of educational and non-promotional materials through VEEVA or other identified platform as per Aspen policies and procedures and ensuring that this material adheres to company policies and processes.
• Ensuring that compliance monitoring is performed on all territories and escalate non-compliance in a timely manner to line manager as per Aspen group policies.
• Supporting the line manager in developing and maintaining the process for managing compliance monitoring process.
• Supporting the training department in providing recommendations for improvement and compliance with Aspen group policies following compliance monitoring review.
• Supporting the line manager in generating reports on activities associated with compliance monitoring activities.

REGULATORY AUTHORITY SUBMISSIONS (INCLUDING SECTION 21/36)

Responsible for:

• Ensuring a comprehensive understanding of the competent health authority’s requirements (Regulations and Guidelines).
• Performing clinical due diligence for new intellectual property as received from the regulatory function.
• Creating professional information and patient information leaflets for new IP.
• Creation of company core data sheets.
• On time responses to clinical evaluation recommendations.
• Accurate compilation and filing of the electronic submission documentation.
• Accurate completion of all tasks pertaining to submissions as specified in the relevant procedural documents.
• Maintaining tracking tools to ensure on submission and reporting.
• Identifying process enhancements.

IMPLEMENTATION OF RISK MANAGEMENT PLAN (RMP) MATERIAL

Responsible for:

• Ensuring that RMP material is created, maintained and rolled out to market.
• Ensuring that the relevant sales force team is adequately trained and training records are filed.
• Ensuring that tracking tools are in place to ensure logging of material distribution and reporting to SAHPRA.

QUALITY MANAGEMENT SYSTEMS

Responsible for:

• Maintaining procedural documents for MI function as specified in the individual KPAs (as per identified subject matter expert).
• Ensuring accurate and ‘real-time’ filing of training records.
• Ensuring ‘real-time’ maintenance of TrackWise records.
• Ensuring that relevant documentation requested by auditors is provided in a timely manner during internal and external audits.
• Ensuring that training records are up to date to ensure audit readiness.

MAINTENANCE OF THE ASPEN/ETHICARE MEDICALLY CRITICAL LIST

• Responsible for initiating and finalizing a bi-annual review of the Aspen/Ethicare medically critical list.

GENERAL

Responsible for:

• Ensuring systems and procedures are in place in accordance with the RA QMS and that these are maintained according to the relevant SOPs
• Adherence to agreed Key Performance Indicators (KPIs).
• Support the continuous development and improvement of the MI function while upholding Aspen core values.
• Effective management and utilisation of resources to keep processes cost effectiv
• Ensuring relevant records are maintained as soft copies and hard copies, as per Pharmacare filing structure/instruction.
• Adherence to Company Health & Safety procedures.
• Participation in training programmes.
• Any other duties as assigned by Manager.

Other

• Creation and maintenance of professional information and patient information leaflets.
• Management of Section 21 and 36 submissions.
• Implementation of risk minimization measures in market as per the requirements set out in approved Risk Management Plans.
• To provide a leadership role by taking responsibility for specified areas and coaching of staff.

KNOWLEDGE

• Understanding the applicable regulations
• Dissemination of regulatory changes
• Terminology – understanding the jargon
• Understanding business processes
• Change control
• Microsoft Office
• Medical Information
• Information Source Material
• Information Management

SKILLS AND ATTRIBUTES:

• Integrity, good work ethic and ability to meet deadlines
• Self-starter
• Problem solving skills
• Accuracy and attention to detail
• Effective organization skills and ability to prioritize
• Ability to work under pressure and to tight deadline
• Ability to work in a fast-paced international environment
• Ability to manage projects in a matrices team environment and with both internal and external partners
• Willing to travel if required
• Presentation skills
• Time management
• Service orientation
• Decision making skills
• Customer focused
• Interpersonal sensitivity
• Self-confidence
• Organisational awareness
• Information seeking

• Excellent interpersonal and communications skills
• A solutions provider
• Manage evolving deadlines effectively with regular feedback and updates
• Enthusiasm and drive to take ownership and drive process initiatives
• Logical thinking
• Positive ‘can – do attitude’
• Work autonomously and have good problem-solving skills
• Able to cope with evolving deadlines effectively with regular feedback and updates
• Honest and trustworthy
• Respectful and highly personable
• Possess cultural awareness and sensitivity
• Flexibility and confidentiality
• Positive and pro-active approach to business tasks
• Enthusiasm and drive to take ownership and drive process initiatives
• Business process analysis
• Report writing
• Information gathering and monitoring
• Projects (advantage)

EDUCATION & EXPERIENCE:

• Bachelor of Pharmacy Degree and registration with the South African Pharmacy Council
• Multilingualism would be an advantage

• Clinical training is a requirement
• Working with remote team is considered as an advantage
• Minimum 3 to 5 years’ experience in Medical Information unit
• Effective use of appropriate IT systems and programs
• Ability to work with multi geographical locations & time zones.

Aspen is committed to the principles of equal employment opportunity and suitably qualified job applicants are invited to submit their CV online on or before the 26 April 2021. Preference will be given to applicants from designated groups through a fair recruitment and selection process in accordance with laws governing employment equity, where such laws are applicable to the Aspen entity that will employ the successful candidate. If you have not heard from the HR department within 30 days of this advert closing, please consider your application unsuccessful.

Internal Applications must be completed using an Aspen mailing address after applicants have had informed their direct line managers of their application.