Regulatory affairs & Tenders Assistant/ PV Local backup officer
Bin Saqar Al Mufid Pharmaceuticals Company L.L.C.
Total years of experience :3 years, 10 Months
Responsibilities:
1. Drug Store Pharmacist in Charge
1. Maintaining the drug store performing as per the listed MOHAP/HAAD guidelines and regulations, Ensure medications are stored in the correct manner, Temperature and Humidity, and keeping all tracking record.
2. Checking on regular basis the validity of all the certificates related to the Company, in order to assist in applying and following up for any renewals or changes.
2. Regulatory and Pharmacovigilance :
A- Registration:
1. Regulatory Affairs department, ensure that products (drugs, medical devices, general sale products, etc.) Comply with all of the regulations and laws.
2. Provide evidence for manufacturing, marketing, clinical research, and Pharmacovigilance to regulatory authorities. Either for new registration, approval for renewal, or Minor Change process.
3. New Drug: preparing and submitting the relevant regulatory dossiers to health authorities in every stage of development of a new medicine and in the post-marketing activities.
4. Minor Change: preparing and submitting the relevant regulatory dossiers to health authorities in every stage with authorised medicinal products have been under Minor Change process (Art work, Leaflet etc.)
5. . Keeping a backup of all the CDs \[administrative information and studies\] received from principle companies related to registration dossiers,
6. Requesting appointments for all types of submission \[classification, registration, others\],
7. Coordinate with the supply chain to insure approval for importing permits and smooth importing process.
8. Apply for HAAD Drug code, and assist in application process for Dubai Drug code.
B-Pharmacovigilance:
(Local Backup Pharmacovigilance officer)
1. Assisting the PV Officer in receiving and recording ADR’s received from healthcare professionals and/or consumers.
2. Communicating with the principle companies regarding any updates or PV surveys, and forwarding the ADRs to the companies
3. Implementing re-call procedure as per local Regulations.
4. Risk management plan.
3. Tenders:
5. Responsible in checking online portals (mainly local authority/government), looking for BID/tender opportunities, preparing and submitting of appropriate tender documentation to successfully process the BID.
6. Receive and respond for requests for quotations from customers.
7. Assist other employees in submitting online import permits.
8. Maintaining database and filing system for all the submitted tender proposals/quotations.
9. Coordinate with the Supply chain to ensure successful supply for vendors before deadline.