Actively participating in the Signalling Meeting, Drug Safety Committee, and Labelling Committee – and Reviewing or drafting responses to requests on all drug safety matters from Regulatory Authorities for product Reviewing or drafting responses to requests on all drug safety matters from Regulatory Authorities. Involvement for Client products. Actively participating in the Drug Safety Committee – signal detection and risk evaluation writing and risk management. Experience of orphan drug/rare diseases/biologics preferred. Understanding
Actively participating in the Signalling Meeting, Drug Safety Committee, and Labelling Committee – and Reviewing or drafting responses to requests on all drug safety matters from Regulatory Authorities for product Reviewing or drafting responses to requests on all drug safety matters from Regulatory Authorities. Involvement for Client products. Actively participating in the Drug Safety Committee – signal detection and risk evaluation writing and risk management. Experience of orphan drug/rare diseases/biologics preferred. Understanding
Manage the contractual relationship with various drug manufacturers as relates to incentives Manage the (1) Supplier Engagement/Contract Management; (2) Drug Development & Regulatory Processes Lead the (1) Supplier Engagement/Contract Management; (2) Drug Development & Regulatory Processes. Also, manage aspects such as payments to CHAI and incentives to drug manufacturers Report monthly on key achievements Stringent Regulatory Authority (SRAs), National Drug Regulatory Authorities (NDRA), Ministries of Health
Manage the contractual relationship with various drug manufacturers as relates to incentives Manage the (1) Supplier Engagement/Contract Management; (2) Drug Development & Regulatory Processes Lead the (1) Supplier Engagement/Contract Management; (2) Drug Development & Regulatory Processes. Also, manage aspects such as payments to CHAI and incentives to drug manufacturers Report monthly on key achievements Stringent Regulatory Authority (SRAs), National Drug Regulatory Authorities (NDRA), Ministries of Health
experience in counselling/advocacy work as an HIV Counsellor or similar
experience in counselling/advocacy work as an HIV Counsellor or similar Experience in clinical trials would
experience in counselling/advocacy work as an HIV Counsellor or similar Experience in clinical trials would
all participants Maintain an inventory register of drug stocks, laboratory samples, promotional materials
participants
requirements, and identify potential risks. Knowledge of drug development, regulations, and guidelines Strong