Deputy Responsible Pharmacist

2 weeks ago

Johannesburg, South Africa Code Red Recruitment Full time

My client is currently looking for a Deputy Responsible Pharmacist reporting to the Responsible Pharmacist.

**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 and MRA’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 on time to satisfy the requirements of the business.
- Compilation of responses to all allocated SAHPRA pre-registration recommendations within 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 to latest 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 authorizations with dates; new products launched; product withdrawals, with dates and reason forwithdrawal, product licenses dropped due to reasons other than safety).
- Provide global pharmacovigilance department with sales data and regulatoryinformation, on request.
- Keep abreast with applicable South African laws, rules and regulations and keep globalpharmacovigilance department informed of significant developments relating to pharmacovigilance

**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 Aurogen South Africa (Pty) Ltd.
- Have appropriate qualifications and experience in the services being rendered byAurogen South Africa (Pty) Ltd.
- Ensure that persons being employed by Aurogen South Africa (Pty) Ltd and whoprovide 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/herservices as responsible pharmacist have been or will be terminated.
- Take corrective measures in respect of deficiencies with regard to inspection reports ofthe Pharmacy Council or in terms of the Medicines Act; and
- In addition to the general responsibilities also
- Ensure that unauthorized persons do not obtain access to medicines or scheduledsubstance or the pharmacy premises outside of normal trading hours;
- Establish policies and procedures for the employees of the pharmacy with regard tothe acts performed and services provided in the pharmacy;
- Ensure the safe and effective storage and keeping of medicine or scheduled substancein 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 AssurancePharmacist;
- Compile a letter of delegation of authority in her/his absence;
- Control the manufacturing or distribution of medicines, scheduled substance or medicaldevices 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 p

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