Pharmacist - Regulatory Affairs
AMICO
Total des années d'expérience :10 years, 8 Mois
Responsible for RA & QA, resolving all concerns and issues related to the custody and storage of all AMICO products.
Communicating with principle companies in order to get documents for Product registration, Import/Export & Advertisement approvals.
Preparation of Dossier for the registration, renewal, classification & minor variation of all the products for which we are the exclusive distributors.
Ensures warehouse follows GSDP standards as per SOP to meet the QA requirements of MOH, Novartis, Medtronic, Arthrex, J&J etc. and successfully completing annual inspection audits.
Responsible for Temperature mapping study & Real time temperature monitoring system of warehouse to ensure Quality requirements of Suppliers.
Responsible to manage collection, processing, documentation, follow-up of ADRs & reporting to Pharmacovigilance team of Novartis- ALCON, Medtronic & other Vendors.
Coordinating over 250+ Shipments per month for MOH Import permits also approvals related to MONTAJI-DM, NMC, FANR, MOCCAE.
Responsible for the Storage & Inventory of Dangerous Goods & Permits from Dubai Municipality.
Visiting MOH, DHA, DM, ESMA, TRA, FANR, NMC, HAZMAT, DCD & Economic Department for all concerns related to product registration, import & other drug store requirements.
Ensures timely renewal of Drug sore, Expiry Management & Waste disposal process as per MOH & DM Guidelines.
Established relationships with regulatory officials to achieve positive outcomes on product approval.
Giving extensive support to AMICO Qatar, Oman, Kuwait team regarding Regulatory Affairs.
ancillary staff in fulfilling more than 1, 400 prescriptions weekly.
•Having good knowledge of handling OTC products & Supplements.
•Coordinator for Insurance prescriptions, dealing with 25+ TPA Companies.
•Reads physicians orders and delivers medications as required.
•Performs initial check for pediatric doses to check appropriateness based on age and weight.
•Provide information and advice regarding drug interactions, side effects, dosage and proper medication storage
•Counseled public on prescription and non-prescription medications.
•Generating Sales by Cross promotion.
•Experience in dealing with Medical devices & equipment’s.
•Responsible for ordering, purchasing, stocking/storing and handling of pharmaceutical supplies, drugs and medical supplies in the pharmacy.
Excel Pharma Kollengode, as
courses: ISO 13485 Internal Auditor •The British Standards Institution – BSI . P.G Diploma in
•Mahatma
in
in Online-