Job Description

KEY RESPONSIBILITIES BELOW:Compliance

• Manage all pre- and post-registration SAHPRA commitments including, but not limited to validation reports, stability data and batch documentation
• Manage the GMP compliance of API and manufacturers and report any current or potential deficiencies affecting current operations and/or new launches
• Conduct and/or assist with Pharmacovigilance inspections as and when required.
• Assist your manager with recall compliance activities, and audit readiness as and when required
• Monitor CCP status and associated tasks in collaboration with Regulatory and assist with identifying delays and gaps affecting marketed products, quality processes and dossier requirements
• Assist with the management of legal operating procedures (Recall and Pharmacovigilance)
• Monitor compliance of current dossiers in line with SAHPRA approvals, product history and pending approvals.

Pharmacovigilance

• Assist in managing and maintaining a system and an App which ensures that information regarding all suspected adverse reactions reported to the company or organization, including to medical representatives is collected and collated so that it readily available and in line with SAHPRA guidelines

• Assist in serving as a contact person for the SAHPRA and, in particular, the NADEMC for all matters relating to vigilance.

• The preparation of the following, either directly or by delegation/supervision, for submission to the Authority
• adverse drug reaction reports
• summary report of ADRs
• Periodic Safety Update Reports (PSURs), when necessary
• Manage the maintenance of Pharmacovigilance agreements with all suppliers in line with SAHPRA guidelines.
• Reporting to Lupin on all Pharmacovigilance activities

Marketing Compliance and Support:Assist in reviewing all advertising and promotional material in line with current legislation, business needs and within agreed timelines

• Assist with the compilation, review and approval of marketing advertising and/or promotional concepts
• Assist in ensuring all web-based product information is accurate and current

Compliance Reviews

• Assist in managing the compliance of regulatory documentation, including but not limited to:

• Clinical safety updates
• Artwork compliance (new and current)
• Any ad hoc SAHPRA requirements, requiring the review, technical assistance and/or compilation of documents
• Implement all identified gaps and control points for Scientific Department

Technical queries and complaints

• Manage product-related technical queries internally and from consumers or other healthcare professionals.

PRE-REQUISITES

• B. Pharm registered with the SA Pharmacy Council.
• Minimum of 2 years Compliance Pharmacist with hands-on experience within the pharmaceutical industry.
• Knowledge of the Compliance and Pharmacovigilance environment within the pharmaceutical industry.
• Working knowledge of Pharmacovigilance and Technical queries, in line with current legislation, operational requirements, and business needs and marketing code.
• Working knowledge of the requirements and process of batch release to the market.

Pharma Dynamics