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Medical Information and Compliance Pharmacist

1 month ago

Johannesburg, South Africa Aspen Pharma Group Full time

**COMPANY DESCRIPTION**

We are a global specialty and branded pharmaceutical company, improving the health of patients across the world through our high quality and affordable medicines. Active at every stage of the value chain, we are uniquely diversi?ed by geography, product and manufacturing capability.

Aspen is a dynamic organisation built on entrepreneurial strength and forward-thinking minds. We attract high performing individuals who are passionate about their career and have a desire to exceed expectations. At Aspen, not only do we source for the best talent but we also provide a host of opportunities for continuous development.

The Group’s key business segments are Manufacturing and Commercial Pharmaceuticals comprising Regional Brands and Sterile Focus Brands. We have approximately 9 100 employees at 69 established officesin over 50 countries and we improve the health of patients in more than 150 countries through our high quality, affordable medicines.

**OBJECTIVE OF ROLE**

To support the SA Commercial Business to realise the commercial strategy and to achieve the annual targeted growth and revenue through successful new product introductions and maintenance of current product portfolio in the South Africa and South African Development Community (SADC) region, by ensuring successful Marketing Authorisation and variation approval from the SAHPRA and Regulatory Authorities of the SADC member states within the committed timeframe.

To ensure Aspen Pharmacare’s SA product portfolio complies with the related Acts and guidelines to support and maintain registration in South Africa. To ensure growth and sustainability of Aspen Pharmacare’s SA product portfolio within the legislative framework of the country and in compliance with the company strategy.

The role undertakes responsibility for compliance with the Regulatory Medical Information and Compliance requirements for the New Product Launch Pipeline and the existing product portfolio in the region, through the successful completion of assigned activities according to the South African and SADC Regulatory plan.

To perform Medical Information and Compliance monitoring activities for Aspen in accordance with procedural documents and relevant governing group policies.

To meet the needs of healthcare providers and patients/consumers through collaboration with internal customers to ensure delivery of accurate and scientifically balanced medical information, and promotional and non-promotional material, and to respond to unsolicited inquiries from regulatory authorities, including clients and managed healthcare organisations in a manner that will help them make a decision regarding therapy for a patient or product selection.

**KEY RESPONSIBILITIES**:
**FINANCIAL**
- Effective utilisation of resources to keep processes cost effective.
- Adhering to Regulatory Affairs budget and forecasts.

**MEDICAL INFORMATION (MI)**
- Providing support within the MI function in responding to labelled and off-label medical information enquiries for Aspen and contractual partners.
- Providing compliant responses to internal and external customers.
- Creating and maintaining standard responses (SRs) and Objection Handlers (OHs).
- Ensuring that the relevant department/s are informed in a timely manner (at receipt or at least within 24 hours) following the receipt of adverse events or product quality complaints/potential counterfeit medicines. This include performing a daily check on the dedicated medical information inbox and MAfax inbox.
- Ensuring that Affiliate/Distributor/MI is adhering to Aspen’s Policy in providing scientific support to internal and external customers.
- Identifying gaps and suggesting ways of process improvement in MI.
- Ensuring that the reconciliation between the Medical Information function and Pharmacovigilance and the 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 Lead at the point of identification.
- Supporting the line manager in generation of medical information reports showing trends in medical information enquiries received.
- Managing after hour MI enquiries on a rotational basis.
- Ensuring telephony system testing documents are completed as per allocation.
- Ensuring compliance to Key Performance Indicators (KPIs) response timelines.
- Ensuring a professional attitude is displayed when responding to a customer’s needs.

**PROMOTIONAL MATERIAL, SCIENTIFIC MATERIAL REVIEW AND COMPLIANCE MONITORING**
- Reviewing and approving promotional material relating to the advertising and promotion of medicines and related products for the SA and SADC markets in compliance with applicable legislation, codes of practice and any other applicable regulations/guidelines and corporate requirements.
- Reviewing and approving educational, scientific and other non-promotion