Syeda Areeha Tatheer
Qualified Person for Pharmacovigilance
Abu Dhabi, UAE
Summary
Qualified person for pharmacovigilance with 3+ years of experience in pharmacovigilance and 1 year of experience in clinical practice. Seeking an opportunity to expertise in the field of PV together with contributing to organizational growth.
Overview
4
4
years of professional experience
22
22
Certification
Work History
Qualified Person for Pharmacovigilance
Hayat Biotech
06.2021 - Current
- Responsible for Oversight of the Pharmacovigilance System.
- Responsible for Developing a thorough knowledge of products, attending training sessions, and developing capabilities continuously.
- Ensure compliance with regulatory standards, accuracy, and timeliness of all prepared documents and reports relevant to products.
- Provide PV training to ensure that all new employees, affiliates, and third-party vendors are trained.
- Preparation and review of Pharmacovigilance System Master File.
- Preparation and Review of Risk Management Plan.
- Preparation and Review of Periodic Safety Update Reports.
- Preparation and Review of Pharmacovigilance standard operating procedures.
- Keep up to date with changes and developments in PV regulations and guidelines.
- Responsible for end-to-end case processing (from data entry to medical review) in the PV Safety Database
- Local Literature Surveillance
- Responsible for gap Analysis of Various PV Documents and Module 5 (Clinical Trial Studies) in the CTD Dossier.
Qualified Person for Pharmacovigilance
Yashfin Consultancy Services
04.2021 - 06.2021
- Reviewing Pharmacovigilance System Master File
- Reviewing Periodic Safety Update Report
- Reviewing Risk Management Plan
- Reviewing PV SOPs
- Local Literature Monitoring
- Responsible for Case Triage and Allocation to the team and managing the workflow.
- Performing Data Entry, Medical Review, and Quality Reviews of the received cases in the PV Safety Database.
- Responsible for providing PV Training to all PV staff and third party vendors.
Qualified Person for Pharmacovigilance
Bio Link
02.2020 - 02.2021
- ICSRs end to-end Case Processing and Follow ups
- Local Literature Monitoring
- Aggregate Report Writing
- PSMF Writing
- RMP Writing
- Conducting interviews with HCPs and patients
House Officer
Fatima Hospital
02.2019 - 02.2020
- Rotated in Internal Medicine, Pediatrics, General Surgery, and Orthopedics.
- ·Attended inpatient, outpatient, and emergency departments.
- Provided patient care by conducting patient’s detailed medical history, detailed General and Systemic examination, daily ward rounds, and documented daily progress notes.
- Performed follow-up with health care professionals for medical evaluation of cases.
- Provide accurate and timely responses to medical information inquiries.
- Participated in team meetings with seniors and provided regular feedback and updates from patients.
- Triage, case processing of both serious and non-serious in the Emergency department.
- Assisted in different Medical and Surgical procedures.
- Managed care of in-house Medicine, surgical, and pediatric patients
- Monitored post-operated patients.
- Performed minor surgical procedures (suturing of wounds, infiltration of local anesthesia, excisional biopsies).
Education
Bachelor of Medicine And Bachelor of Surgery -
11.2019
Skills
- Good Analytical and Problem-Solving Skills
- Attention to Detail
- Root Cause Analysis
- Compliance Training
- Effective communication skills
- Strong organizational skills
- Systemic approach, Quick grasping, and Well-disciplined
- Committed to the assigned work
- Ability to work in teams
- Good level of computer literacy with Microsoft applications
Certification
- PVCON CONSULTING - Pharmacovigilance Foundation Course
- PHARMA LESSONS - Good pharmacovigilance Practice training
- BIOPHARMA INSTITUTE - Introduction to Drug Safety & Pharmacovigilance – An abridged Course
- WHO E-LEARNING
· Vaccine Safety Basics
· Investigation of Adverse Events Following Immunization
- UPSALA MONITORING CENTER
· Introduction to pharmacovigilance
· Causality assessment case series
· Signal assessment
· Causality assessment of sisingle-caseafety reports
· Introduction to signal detection
· Statistical reasoning and algorithms in pharmacovigilance
- VIGISERVE FOUNDATION
· Pharmacovigilance basic 1
· Pharmacovigilance basic 2 (industry-oriented)
· Aggregate case safety reporting
· Safety Data exchange agreements
· Signal and risk management
· Pharmacovigilance system master file
Languages
English
Bilingual or Proficient (C2)
Urdu
Bilingual or Proficient (C2)
Timeline
Qualified Person for Pharmacovigilance - Hayat Biotech
06.2021 - Current
Qualified Person for Pharmacovigilance - Yashfin Consultancy Services
04.2021 - 06.2021
Qualified Person for Pharmacovigilance - Bio Link
02.2020 - 02.2021
House Officer - Fatima Hospital
02.2019 - 02.2020
Baqai Medical University - Bachelor of Medicine And Bachelor of Surgery,
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