Job Description

KEY RESPONSIBILITIES

Compliance and Pharmacovigilance responsibilities

• Ensure compliance of current dossiers in line with SAHPRA approvals, product history and pending approvals as well as in neighboring countries e.g. CEP, validation and stability information
• To ensure the integrity of data of any current or potential Regulatory/Quality databases and processes e.g. validity of certificates
• Ensure the accuracy of the CCP database information and timeous closing of CCPs
• Manage the implementation, recording and control of a Master List of products accurately
• Monitor non-conformance of variations in dossiers and Professional information/ Patient information leaflets in Export countries
• Check all Professional information/Patient information leaflets content according to a checklist provided
• Tracking of Professional information/Patient information leaflets Safety updates and availability and market implementation
• Track timeous updates of Pharmacovigilance Professional information/Patient information leaflets and market implementation
• Track updated Professional information/Patient information leaflets availability on the website
• Assist with the update of all Product appendices of Pharmacovigilance Agreements and queries
• Assist with the preparation of audit readiness
• Assist with obtaining risk reports in liaison with Lupin and Export division
• Ensure timeous upload of all training material on Policy Passport and printing of monthly status reports
• Assist with identifying any potential gaps and/or non-adherence to SAHPRA requirements and Quality Management System
• Assist with tracking of any outstanding actions relating to risk reports and/or identified gaps

Documentation & Systems Management

• Assist with the compilation and tracking of Compliance, Pharmacovigilance, Regulatory and Quality activities
• Assist in adherence to SOPs and departmental deadlines
• Assist with Launch checklists

General * Perform any other duties as per changes in operational requirements of the departments.

• Perform any other duties as requested

PRE-REQUISITES

• BSc. Degree with Physiology as a main subject

TECHNICAL COMPETENCIES REQUIRED

• Excellent computer skills which includes working on electronic databases, as well as a good knowledge of software packages such as Word and Excel.
• Good knowledge and proven application of administration processes, systems and practices.
• Knowledge of the pharmaceutical industry is a strong advantage.

BEHAVIOURAL COMPETENCIES REQUIRED

• Professional and presentable.
• Good communicator with excellent interpersonal skills.
• Excellent prioritization and time management skills.
• Good planning and organizing skills.
• Self-discipline.
• Effective administration skills.
• Excellent attention to detail and must be able to concentrate on detail aspects.
• Positive attitude.
• Self-motivated.
• Able to adapt to change.

Pharma Dynamics