Dr Ume Asma

Pfizer COVID-19 Vaccine Safety BNT162 B2 post-Marketing Surveillance

- Vaccine Safety case reports assessment of SAE for Clinical Trial BNT162B2 marketed for Covid Vaccination worldwide

- Pfizer Covid-19 safety guidelines implemented for adverse event reporting to ethics committe .FDA ,EMA and worldwide regulatory authorities -

- Lead and compiled CAPA management of vaccine safety data review for vendor site Qinecsa solution India site

-Weekly /Monthly client trainings for safety data conventions AandBNT162B2 vaccine guidance documentations implemented for evidence based world wide AE medical review guidelines.

- Internal workflow management , business process improvement ,vendor quality team collaboration and audit process inputs for safety audits completed successfully for Pfizer vaccine project.

- Operational management for Regulatory submissions and SDEA and License Partner Submission Compliance timelines monitored

Interim Consultant for Nordic projects and cosmetovigilance as consultant for start- up pharmacovigilance company

Novartis Pharmaceuticals - SERM physician

Ipsen Pharma Regulatory Consultant (2019)

SME Primary product portfolio – Oncology and Immunology.

Novartis Therapeutic Area Experience (ADR Reports) Transplant Products |Immunology| Respiratory products| Established Medicine| Antibiotics| Cardio-metabolic | Neurology| Gastroenterology| |Dermatology| |Wound healing| Urology | OBGyneac |Hemato -oncology-JAKAVI | Lung cell carcinoma Trials (AOSE:Phase1) |Infectious Disease |Metabolic Disorders| Anaesthesia |Psychiatry| |Immunology| New Drug Development process Phase1phase 4 studies. • . Brexit Guidelines, GVP Guidelines, REMS, ICH GCP guidelines, Regulatory guidelines of US FDA, EMEA and other regulatory bodies, Schedule y guidelines ,NDA ,ANDA,GMP, 21 CFR Part 11 • Performed quality assurance of project delivery within the service line, ensuring client satisfaction and quality of work validated according to agreed processes • Setting up new projects and actively involved in project transitions from client site to India Offshore delivery centres. • Lead project teams, task forces and/or working groups to identify opportunities for strategic alignment of quality and compliance processes and process improvements. • Collaborated with the therapeutic area leads regarding review of safety processes and/or documents that may affect projects, processes, product delivery • Liased with all other onshore and offshore therapeutic area and shared service roles to promote consistent operations, efficient use of resources and sharing knowledge/best practices • Supported Executive Management in compliance status reporting of the deals – Pharma Compliance, Critical Security Metrics and any other compliance metrics • Delivered on client commitment to people and their development, providing leadership and driving development of individuals through People Development Groups • Lead recruitment activities in line with demand for services • Designed and delivered training and development activities to build internal skills and capabilities within the service line

Academic Programmes Faculty: /University Examiner

Advanced Clinical Research

Pharmacovigilance and Clinical Trial Management

• Pre/Post Marketing Case Safety Report Experience: CIOMS/MEDWATCH/E2 B
• MHRA/literature/AOSE/Signal/PADER/SUSAR /SMO , Investigator roles clinical trial study management ,IB, ERB
• Signal detection ,aggregate and risk management safety reports.

EMR informatics project implementation for US clients

• General Physician
• Immunisation programes , women and child health ,ante-natal care
• Geriartric and minor surgical procedures
• Nutrition and mental health counselling