Dr. Intesar K. Email & Phone Number

Full-time General Practitioner and subject matter expert for ALWIS for IT & AI-based Pharmacovigilance and Medical writing solutions.Dear Recruiters, please do not approach me for Pharma industry jobs. Dear Freshers, you could approach me for any queries related to Pharmacovigilance, Medical writing or overall Pharma industry.Overall Pharmacovigilance and Medical writing experience include - Signal Management; Risk Management Plan including preparation, distribution strategy and measures of effectiveness of additional RMM materials in EU and non-EU countries including India; Clinical Expert statement; CCDS; author & reviewer of aggregate reports (PADER, PSUR, and PBRER), Addendum to Clinical overview, and US annual reports; Triage of literature cases; Summary of PI updates; Preparation of Safety management plan; Review of clinical study documents (e.g. Protocol, ICF, eCRF, SAP); and author & reviewer of CSR (Phase I-IV), including CSR safety narratives, IB updates, Summary documents (ISS, ISE, CO, Article 45, Response documents to regulatory agencies).MiscellaneousAssisted internal and external stakeholders for preparation of product website, newsletters, and educational material (as a part of RMM for RMP). Interaction with Regulatory affairs team, document publishing, Biostats & programming team, Preparation of narrative template, Collaborated with regional teams for project work, SOP, QC, Audit, and Medical query handling.