Deputy Responsible Pharmacist

3 weeks ago

Johannesburg, South Africa Immploy Recruitment Full time

Job Description

DEPUTY RESPONSIBLE PHARMACIST

In the absence of the Responsible Pharmacist, the Deputy Responsible Pharmacist contemplated in regulation 25 (3) of the Pharmacy Act and the relevant sections of the Medicines Act shall:
Ensure that he/she in fact continuously supervises the Client.

Have appropriate qualifications and experience in the services being rendered by the Client.

Ensure that persons being employed by the Clientand who provide services forming part of the scope of pharmacy practice of a pharmacist areappropriately registered with the Pharmacy Council.

Notify the Pharmacy Council immediately upon receiving knowledge that his/her services as responsible pharmacist have been or will be terminated.

Take corrective measures in respect of deficiencies with regard to inspection reports of the Pharmacy Council or in terms of the Medicines Act; and

In addition to the general responsibilities also
- Ensure that unauthorised persons do not obtain access to medicines or scheduled substance or the pharmacy premises outside of normal tradinghours.

Establish policies and procedures for the employees of the pharmacy with regard to the acts performed and services provided in the pharmacy.

Ensure the safe and effective storage and keeping of medicine or scheduled substance in the pharmacy under his or her direct personal supervision.

Have the overall responsibility for release of the finished products to the market.

Ensure correct and effective record keeping of the purchase, sale, possession, storage, safekeeping and return of medicines or scheduled substances.

Initiate and coordinate all recall activities which should involve the Quality Assurance Pharmacist.

Compile a letter of delegation of authority in her/his absence.

Control the manufacturing or distribution of medicines, scheduled substance or medical devices in terms of the provisions of the Medicines Act, 1965.

Ensure that there is compliance with Good Pharmacy Practice as published by the Pharmacy Council.

Be part of the decision-making process affecting the pharmacy business.

Ensure that the pharmacy owner complies with all conditions of
- Ownership of such pharmacy business
- Registration of the pharmacy

**Minimum Qualifications**:
BPharm

**Experience Required**:
1-year Regulatory Affairs/Quality Assurance experience preferred.

Exposure to production would be an advantage.

**REGULATORY AFFAIRS**:
1. Delivery of New Product Submission Plan

Submission of new dossiers as per the annual product submission plan to SAHPRA andMRA’s of other designated territories according to the latest guidelines.

2. Delivery of Future Registrations

Continuous liaison with SAHPRA to ensure new product registrations are received ontime to satisfy the requirements of the business.

Compilation of responses to all allocated SAHPRA pre-registration recommendationswithin a stipulated time frame.

Physical and electronic superseding of the dossier with pre-registration responses.

3. Life Cycle Management

To ensure that necessary variations are made to the Registration Dossier according tolatest requirement of the MRA.

To ensure timely submission and approval of variations.

To ensure that the MRA is informed of changes to the registration dossier.

To ensure the company is made aware of any approvals, queries, and rejections fromSAHPRA regarding any variations.

4. Printed Packaging Material (PPM) Development and Control

Review of all PPM for launch products

Assist in the maintenance of all PPM’s and implementation of any regulatory changesto PPM’s as required,

To ensure PPM development and approval within stipulated timeline to ensure no delays in launch,

5. Review of promotional material against the Marketing Code

6. To evaluate the Regulatory impact of change controls

7. Assisting the Responsible Pharmacist with Pharmacovigilance related activities below as and when required.

Collection of adverse event and drug safety data and reporting/forwarding it to the global pharmacovigilance department within 4 calendar days of receipt of the ADR.

Submission of individual case reports to the South African regulatory authority in a timeous manner, and record keeping.

Providing pharmacovigilance training and documenting these training activities.

Completing and forwarding a monthly pharmacovigilance compliance report to global pharmacovigilance department (Report to include new product authorisations with dates; new products launched; product withdrawals, with dates and reason for withdrawal, product licenses dropped due to reasons other than safety).

Provide global pharmacovigilance department with sales data and regulatory information, on request.

Keep abreast with applicable South African laws, rules and regulations and keep global pharmacovigilance department informed of significant developments relating to pharmacovigilance.

Between 3 - 5 Years

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