Shahida Hasan

Background

About Shahida Hasan

International Medical Graduate with 20 years of clinical experience combined with 15 years of Pharmaceutical industry experience, covering Drug Safety, Pharmacovigilance, Medical Affairs and Clinical Operations. Strong skills in: • Clinical Pharmacovigilance: Receipt, handling and regulatory submission of SAEs from Global Clinical Trials. • Post-marketing Pharmacovigilance oversight of company products, including receipt and processing of adverse events, reviewing for reportability and ensuring timely submissions, signal detection and evaluation, updating labels for Safety and PLR information. • Medical writing, Review of PSURs, PADERs, Annual Safety Reports, RMPs DMETs reports, including evaluating trends/signals. Review Safety Project Plans. Oversight of Safety CROs • Medical Monitoring for clinical trials. • Protocol development, amendments, forms, manuals, CRFs, CSRs other study documents • Medical Information, responses to inquiries, researching drug history and latest information, evaluating drug candidates for development. • Reviewing and creating sales training material, review promotional material. • Liaising internally with other departments, R&D, Clinical Development, Clinical Operations, Sales and Marketing, Compliance, as well externally with KOLs, CROs, HCPs