POSITION : RA/QA Compliance & Pharmacovigilance Officer
REPORTS TO : QA/Compliance Manager
DIVISION : Pharma

JOB OBJECTIVE

• Ensure company and product compliance with the regulatory authorities.
• Responsible for pharmacovigilance.

TASK DESCRIPTION
Ensure Company and Product Compliance e.g. Site Master File, Licences, Certificates, Retention Fees, etc.
• Ensure that the License is maintained and the necessary requirements for licensing are fulfilled.
• Maintain the Registration certificates of products.
• Ensure that Retention fees are paid timeously to HA.
• Update the SMF and submit.
• Review and draw up the Technical Agreements.
• Handling of Product Recalls
• Deal with any Regulatory Related tasks from time to time

Responsible for PI, PIL and Dossier Compliance Audit
• Review new product PI and PIL before submitting the dossier to SAHPRA
• Draw up Dossier compliance audit plan as required in consultation with RA manager.
• Responsible for Self-Inspection (Marketing & Sales) and participate in third party audits.

Responsible for auditing of approved Master Documentation
• Review and approve the following Master documents:
• Manufacturing documents
• Packing documents
• Specifications

Review and approval of Printed Packaging Material
• Approve product artwork i.e. printed packaging material

Responsible for compilation, review and update of SOPs
• In line with relevant company policies and procedures, in particular those pertaining to QA, RA, PV and Compliance.

Pharmacovigilance
• Set up and maintenance of the company pharmacovigilance system in accordance with Health Authority requirements and guidelines
• Prepare pharmacovigilance SOP’s and issue forms to the business.
• Training of all Ascendis Staff on PV
• Handling of Adverse Events and Customer Complaints
• Notify SAHPRA on product safety issues.
• Provide medical information as per request.



Support function to Marketing and Sales Departments
• Assist the marketing and sales teams with relevant regulatory data
• Review and Approval of marketing artwork and training material.

Purpose: Legislation
• Keep abreast of new developments in legislation, guidelines and recommendations of the various Health Authorities in Africa.
Acquire and maintain technical knowledge and skills relevant to the position by keeping abreast of current literature and attending academic seminars/meetings with respect to new developments in the regulatory affairs and pharmacovigilance arena.

EDUCATION AND KEY EXPERIENCE

Education
• Bachelor of Pharmacy Degree/ BSc degree or /or equivalent
• Registration with the South African Pharmacy Council
Knowledge
• Knowledge of current legislation governing product registration
• Knowledge of current legislation governing drug safety and pharmacovigilance
• Knowledge of other legal requirements impacting the regulatory environment i.e. advertising, trade and metrology, foodstuffs and cosmetics, GMP, etc.
• Knowledge of pharmacology and therapeutics
• Knowledge of operations i.e. quality assurance, quality control and manufacturing an advantage
• Knowledge of basic software packages such as Microsoft Office Suite and Adobe Acrobat.
Experience
• Minimum 6-8 years pharmaceutical experience with at least 3 years in RA/QA /PV and laboratory departments.
• Exposure to the marketing of products and auditing of vendors in the pharmaceutical environment an advantage

Closing date will be the 14th February 2020.

Should you not be contacted within two weeks of your application being submitted, please consider your application unsuccessful.