Locum Pharmacist (6 Month Contract) at Aspen Pharma Group

ROLE PURPOSE:

• To perform all regulatory functions related to product quality, safety and efficacy, to update and resubmit previously submitted variations to SAHPRA according to current SAHPRA requirements. To ensure comprehensive and quality submissions to SAHPRA in order to facilitate the shortest possible approval time. To perform these functions under supervision of senior personnel, ensuring that work has been reviewed where required in order to deliver compliant, quality submissions.

SPECIFIC OUTCOMES / ACCOUNTABILITY:

UPDATE AND RESUBMIT VARIATIONS TO SAHPRA

• Updating and compiling previously submitted variations to SAHPRA according to current requirements and guidelines as per departmental procedures, within specified timelines
• Sending requests for dossier information to the relevant departments as required and as per process, within specified timelines
• Evaluating the previously submitted variations against current SAHPRA guidelines and regulations, and as per departmental procedures, within specified timelines
• Obtaining any information that is outstanding in order to complete the variation submission
• Timeously requesting, overseeing and reviewing preparation of electronic or hard copy submissions from/by the relevant support personnel
• Taking responsibility, checking and ensuring quality of the entire submission prior to dispatch/submission
• Following up and ensuring that proof of submission is obtained and saved/distributed according to departmental procedures
• Completing the required administrative functions as per departmental procedures

DEFICIENCY RESPONSES FOR SAHPRA RESUBMITTED VARIATIONS

• Compiling and submitting responses for deficiencies received from SAHPRA for resubmitted variations within specified timelines. Ensuring compliance with SAHPRA requirements, current guidelines and regulations, and as per departmental procedures.
• Reviewing the deficiency letter and forwarding requests for information to the relevant departments within allocated timelines, ensuring that the request is comprehensive and easily understandable to obtain the correct information first time
• Identifying any risks and communicating this to the line manager immediately
• Follow up with the relevant departments to ensure that outstanding data is received in good time
• Timeously requesting, overseeing and reviewing preparation of electronic or hard copy submissions from/by the relevant support personnel
• Taking responsibility, checking and ensuring quality of the entire submission prior to dispatch/submission
• Following up and ensuring that proof of submission is obtained and saved/distributed according to departmental procedures
• Completing the required administrative functions as per departmental procedures

GENERAL

• Administrative support within the department is available to the pharmacists, but the responsibility for quality of the final submission to the regulatory authority remains the responsibility of the pharmacist
• Maintaining electronic folder structure as per departmental procedures
• Complying with regulations, guidelines, policies and procedures
• Adhering to deadlines/due dates
• Timeously escalating to the line manager where possible delays are identified which could impact the due date
• Liaising with relevant internal and external customers to obtain or supply relevant regulatory information or documentation

Requirements

EDUCATION:

• Bachelor of Pharmacy degree or equivalent.
• Regulatory Affairs training and certification a distinct advantage

EXPERIENCE:

• Experience within the pharmaceutical industry in a Regulatory Affairs/Production/Quality/Clinical environment is preferable

ASPEN COMPETENCIES

SKILLS & ATTRIBUTES:

BUSINESS:

Makes Good Decisions

• Information seeking
• Responsibility and accountability

Performance Driven

• Planning and organisational skills
• Focused

PEOPLE:

Communicates effectively

• Active listening skills
• Writing skills 

Dealing with ambiguity and embracing change

• Capacity for and resistance to stress
• Perseverance and tenacity

 SELF:

Contributes Special Expertise

• Technical / professional knowledge
• Industry knowledge

Continuously grows and develops

• Curiosity / learning agility
• High standards