SUMMARY:
Our client is looking for a Drug Safety Manager to ensure that the Company is at all times, compliant with the relevant laws, regulations, and guidelines that govern drug safety and for establishing and maintaining the drug safety systems.
POSITION INFO:
Job Specification
Oversee and direct the pharmacovigilance activities and essential related tasks for the Company
ICSRs (Individual Case Safety Reports) management and assessment as per internal procedures
Act as case owner for assigned ICSRs to ensure accurate completion of data entry (DE), data review (DR), and regulatory reporting (RR), in line with company SOPs
The PVO acts as a product owner for products under the responsibility of Our Client, providing support to PV Scientists/Associates and the Global Drug Safety Division with literature management and aggregate report preparation.
Maintain a high standard of case quality
Responsible for providing a root cause analysis for any late reporting submissions
Management and prioritisation of individual workload
Highlighting any safety-related issues to the attention of the management team
Perform pharmacovigilance checks/evaluations of the Quality Assurance database (Trackwise)
Support preparation of SOPs and product safety reviews
Ensure all allocated CAPAs; Deviations and Actions are closed on time on TrackWise
Keep abreast of changes to PV Legislation and ensure Regulatory Intel is monitored for SA and SSA territories
Pharmacovigilance training of all Our Client employees and distributors/service providers and documentation thereof
Regulatory review key Medical Journals for any adverse drug reaction reports with Our Client products/medicines
Understand SDEA obligations in order to ensure all aspects under agreements are duly executed
Facilitate
Highlighting any safety-related issues to the attention of the management team
Reviewing of Regulatory websites for any potential signals
Support the continuous development and improvement of the PV function
Receipt, evaluation, and reporting of individual case safety report in accordance with international (export territories) and local regulatory requirements and contractual partner obligations
All AE-related queries are to be followed up within the company internal procedures
Submissions of Health Authority Communication letters to SAHPRA
Minimum Requirements
University graduate of a science degree or Masters in a medically related discipline
Pharmacovigilance and/or regulatory experience (min. 5 years) w
Exposure to and knowledge of PV requirements in South Africa and Africa
5 years experience in a pharmacovigilance role covering all areas of the function
Information Management and organisational skills
Effective understanding and use of the principles of information capture, storage, searching, and retrieval
Effective use of appropriate IT systems and programs
Acute Attention to detail
Analytical skills-
Knowledge of the business and of the pharmaceutical industry.
Understanding of the external environment: Government policy, regulatory requirements.
Insight into legal and compliance
Global PV Guidelines
Local PV Guidelines
POPI ACT
Ethics
Understanding of, and compliance with, company policies, legal requirements, and other industry guidelines that are relevant to pharmacovigilance
Kindly note that by submitting your application for this career opportunity you agree that Guardian Recruiting may use your application for the purpose of the recruitment and selection of the said position and this information may be shared with the relevant stakeholders in the business.
Please note that only shortlisted candidates will be contacted.
Should you not have heard back within a two-week period, please assume that your application was unsuccessful. All job postings are in accordance with our Client''s BEE requirements. Please only send certificates when requested to do so.
NB! This job is now closed. You can apply for other jobs by uploading your CV.
