Irine Thomas
Mississauga,ON
Summary
To secure a position in a well-established organization with a stable environment that provides the scope to apply my knowledge and skills to work dedicatedly towards the growth of the organization.
Innovative and proactive result-driven professional with 6 years' experience in safety medical writing and pharmacovigilance. Actively involved in the authoring of various safety reports for global regulatory submissions, including PADER, PSUR, PBRER, ACO and DSUR. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
6
6
years of professional experience
Work History
Senior Drug Safety Associate
Novotech
08.2023 - 10.2023
- Preparation and submission of developmental safety reports (DSUR)
- Provide safety content review of clinical study reports (CSR)
- Support development/maintenance of core and local label for company products (CCDS, USPI, SmPC, IB etc)
- Provides safety expertise for assigned products in terms of benefit-risk assessments and risk management
- Provides safety evaluations and response to safety queries from stakeholders
- Responsible for complete and accurate case processing of adverse event reports.
- Collaborated with cross-functional teams to develop effective risk mitigation strategies for newly identified safety concerns
- Improved regulatory compliance by ensuring timely submission of periodic safety reports to health authorities
- Developed comprehensive training materials and conducted workshops for junior team members to enhance their drug safety knowledge and skills
Safety Evaluation and Risk Management-Scientist
GlaxoSmithKline (GSK)
06.2021 - 06.2023
- Runs routine signal detection process, including review of individual case reports via Case Awareness Tool, literature review, On-Line Signal Management Tool, in partnership with SERM physician, for all products in area of responsibility
- Discusses need for, and priority of safety related findings/ signal reviews with the SERM Team Leader/ SERM physician; communicates, escalates and documents the outcome of signal detection process
- Uses appropriate sources of information and database searches to retrieve relevant data for explorations/ evaluation of signals
- Analyses safety data and discusses the results with the SERM Team Leader/ SERM physician and other key stakeholders, as appropriate
- Produces accurate and fit for purpose exploratory/ evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data with some level of support from more senior personnel, as necessary
- Routinely monitors safety issues potentially related to a product defect and/or manufacturing issue
- Authors periodic regulatory documents (PBRERs) according to the agreed process and timelines
- Supports Local Operating Companies (LOC) by preparing license renewal documentation (e.g Addendum Reports, Line listings, Clinical Overviews) as required for each market
- Author SERM safety contribution to other global regulatory submissions or answers to safety related questions from Regulatory Agencies, with strategic guidance from more senior personnel
- Authors or assists in the production or renewal of global Risk Management Plans/ regional Risk Management Plans for designated products
- Contribute to Regulatory Benefit-Risk Assessments requiring safety team input
- Creates and maintains the Global Product Information (PI) for products supported
- Produces regulatory supporting documentation for labelling updates or variations
- Provides recommendations for labelling changes for Single Market Products, as applicable
- Provides answers to Regulatory Enquiries related to labelling content
- Provides relevant input into regulatory requests for local label deviations from the Reference Safety Information, in cooperation with relevant functional experts (Country Labeling Difference Process)
- Assist in review of Safety Data Exchange Agreements (SDEA)
- For assigned products, give safety input regarding patient safety risk management activities
- Ensures identification and assessment of signals and risks related to regional pharmacovigilance activities
- Conducts review/ assist in review of list of studies and identifies TSS/ PASS status in consultation with senior colleagues
- Accountable for maintaining personal readiness in response to internal audit or regulatory inspection
- Collaborates with other cross functional team including medical affairs, regulatory affairs, pre-clinical and clinical development teams.
Executive-Pharmacovigilance
ClinChoice Pvt Limited
01.2020 - 06.2021
- Manage the production of aggregate reports such as PADER, PBRER etc., for assigned products including planning, conducting meeting and writing
- Perform quality review for the reports prepared by the peered aggregate report writers
- Ensure preparation of timely, quality aggregate reports for assigned products
- Data quality review/correction.
Drug safety associate
Bioclinica Safety and Regulatory Solutions
09.2017 - 01.2020
- Involved in creation and quality review of Aggregate Safety Reports (PSURs, PADER, PBRERs)
- Lead/Co Lead cross functional teams contributing to periodic safety reports in accordance with Global Pharmacovigilance and Risk Management (GPRM) business rules, standard operating procedures (SOPs), and global regulatory requirements
- Review aggregate safety data from the database and generate line listings (LL) and summary tabulations (ST) and include the LL & ST in the appropriate template
- Reviews and identify the literature that is selected for inclusion in the regulatory document that may lead to the signal deduction
- Participate in internal and external audits and inspections by clients and health authorities
- Transcription of medical information from various source documents (Line Listings, CIOMS and Literature), routine searches and assessment of published medical and scientific literature (pubMed, EMBASE etc) for identification of drug safety data
- Maintain awareness of changes to/new regulations affecting pharmacovigilance activities
- Communicate new or changed regulations to management and to relevant members of the department in order to initiate any change in processes
- Train and mentor new employees in pharmacovigilance.
Education
Doctor of Pharmacy (PharmD) -
Kerala University of Health Sciences, Trichur
Kerala01.2017
Skills
- Organizational skills
- Critical thinking capacity
- Regulatory compliance understanding
- Cross-functional collaboration
- Medical writing aptitude
- Case processing abilities
- Signal detection proficiency
- Clinical trial experience
Languages
English
Full Professional
Timeline
Senior Drug Safety Associate
Novotech
08.2023 - 10.2023
Safety Evaluation and Risk Management-Scientist
GlaxoSmithKline (GSK)
06.2021 - 06.2023
Executive-Pharmacovigilance
ClinChoice Pvt Limited
01.2020 - 06.2021
Drug safety associate
Bioclinica Safety and Regulatory Solutions
09.2017 - 01.2020
Doctor of Pharmacy (PharmD) -
Kerala University of Health Sciences, Trichur
Similar Profiles
Joseph HalsteadJoseph Halstead
Budget and Contract Specialist at NovotechBudget and Contract Specialist at Novotech
Lida WilsonLida Wilson
CDA II at NovotechCDA II at Novotech
BUSRA ARSLAN ALMAZBUSRA ARSLAN ALMAZ
Clinical Research Associate III at NOVOTECHClinical Research Associate III at NOVOTECH
Pallavi SPallavi S
AR Specialist at NovotechAR Specialist at Novotech
Harir LateefHarir Lateef
Project Coordinator at RegensisProject Coordinator at Regensis