Clinical Affairs Pharmacist

Job Advert Summary:

Provision of a reliable and efficient clinical affairs service that applies current knowledge and experience of clinical aspects of biological products, including plasma-derived medicinal products, in supporting both internal and external customers, in order to achieve the business and operational objectives of NBI, and to maintain compliance with regulatory requirements.

Specific Operational Requirements

• May be required to work overtime/travel to meet the business needs.
• Must be prepared to work shifts/weekends/public holidays when needed.

Minimum Requirements:

B Sc. (Pharm) or B Pharm

South African Pharmacy Council (SAPC) Registered Pharmacist

Registration with Pharmaceutical Society of South Africa (PSSA)

At least 4 years in a pharmacy practice environment (retail, hospital, health management organisation)

MS Office proficiency

(Word, Excel, PowerPoint, Outlook)

Preferable:

• Literature searching & evaluation skills
• Bibliographic management software
• Databases (MS Access, Lotus Notes, or similar)
• Pharmacovigilance/Drug Safety activities
• Training/Lecturing Skills
• Clinical trial experience
• Postgraduate degree/qualification in Clinical Pharmacy/Pharmacology would be an advantage.

Duties and Responsibilities:

Clinical Information:

• Compilation of clinical dossier modules for NBI's existing products, in the appropriate format.
• Compilation, update and review of clinical information in Professional Information and Patient Information Leaflets.
• Provision of clinical advice within and across other departments within NBI when assistance of a clinical nature is requested.
• Compilation and presentation of clinical assessment reports based on literature reviews for potential new products.
• Compilation of clinical risk assessments relevant to the operational production of NBI's products, including but not limited to clinical evaluation of planned manufacturing changes, deviations and/or outofspecification results.
• Compilation, update and review of clinical information in promotional material and/or items, and in digital/online clinical nonpromotional content.

Clinical Trials and Post-Marketing Studies

• Drafting of clinical study protocols in line with Good Clinical Practice, local and international guidelines and ethics requirements.
• Monitoring of the progress of studies or clinical trials to ensure they are conducted, recorded and reported in accordance with the protocol, Standard Operating Procedures and other applicable guidelines, legislation and regulations.
• Preparation and submission of clinical study reports and postmarketing evaluations for NBI's products to meet regulatory requirements.

Pharmacovigilance

• Receipt, recording and collation of all adverse event reports.
• Evaluation of adverse event reports in the context of product complaints received to identify trends and informing the Clinical Affairs Manager for appropriate escalation.
• Preparation and compilation of clinical Risk Management Plans, riskbenefit assessments, Periodic Safety Update Reports and annual summary reports, and amendments to safety statements in Professional Information and Patient Information Leaflets, to meet regulatory requirements.
• Assistance of the Clinical Affairs Manager to ensure NBI's compliance with regulatory requirements for postmarketing clinical risk management/minimisation activities.
• Evaluation of national and international pharmacovigilance literature and regulatory communications with specific focus on significant safety issues, and proactive communication of such to the Clinical Affairs Manager for appropriate action.
• Monitoring and reporting of new evidence and published information of suspected adverse drug reactions related to NBI's products for further evaluation.
• Analysis of data from the adverse event database for compilation of reports and audits as required.

Pharmacovigilance Education and Training
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Development of training material and presentation of pharmacovigilance training for relevant internal and external stakeholders.

• Training of relevant new staff on NBI's pharmacovigilance obligations, policies and system.
• Planning and presentation of training of undergraduate and/or postgraduate students at Pharmacy Schools on pharmacovigilance.
• Facilitation of Continuing Medical Education for healthcare professionals in the field of pharmacovigilance.
• Compilation and review of clinical presentations and leavebehind pieces used by Product Consultants for customer detailing and training.

Core Competencies

• Managing Relationships
• Personal Leadership
• Business Impact
• Leading and Influencing others
• Good clinical knowledge & skills.
• Excellent interpersonal skills with a strong customer focus.
• Collaboration and teamwork.
• Advanced communication skills (written, verbal).
• Attention to detail, critical and analytical thinking, and problemsolving skills.
• Appropria

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