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Job Description
- Training the employees of the company on the concept of drug vigilance and importance and how to deal with adverse reactions, recording and informing the QPPV.
- For product re-registration, RMP (Risk Management plan report) & ACO (Addendum of clinical overview) should be submitted to EPVC (Egyptian pharmacovigilance center).
- Having an overview of the safety profiles and any emerging safety concerns to the company's drugs.
- Preparing SOP for pharma co-vigilance practice & any related company information.
- Plan the review of a new application submission corresponding to company plan as well as the agency guidelines for submission.
- Plan for the review and submission of all the maintenance activities (renewal & variations) based on company plans and the agency guidelines
- Timely implementation of all plans with strict follow up with both internal & external stakeholders for timely achievement of the plan.
- Maintain the products labeling up to date, implementing global and local labeling decisions, through labeling, review and approval
- Updating the internal DKT DMFs regularly
- Revision and approval of promotional Materials any updated packaging material on VISTA
- Preparation, submission and follow up of pricing files internally and externally
- Following and complying with all the defined internal policies and procedures of working
- Following strictly all the Authority Regulations, decisions & decrees
- Carry out all the required communication and follow up required with local affiliate, region & corporate as appropriate.
- Carrying the planned Activities and reflecting the approvals on the internal system
- Revision and approval of Promotional Materials & any updated packaging material
- Perform other duties as assigned.
- Respect of company’s values, code of ethics and social charter.
- Respect of personal data protection charter
Job Requirements
- Graduated From Pharmacy
