Uma Shankari Ranganathan
Swindon
Summary
Armed with recent experience in the pharmacovigilance field, I am an adaptable and diligent team player. I also seek to utilize my skill on expert level hands-on training in Argus database. Known for my sincerity and empathy in communication, I come ready with essential IT skills.
Overview
12
12
years of professional experience
2
2
years of post-secondary education
1
1
Certification
Work history
Pharmacovigilance Officer
Accord UK-Pvt Ltd
Barnstaple, UK
01.2022 - 10.2024
- Part of high performing team handling compliance for hypercare products (Thalidomide and Lenalidomide)
- Transcribed 1800+ Prescription Authorisation Forms (PAF)/30+ new Pharmacy registration forms in a calendar year with 95% accuracy
- Managed Risk Management Plan (RMP) Team inbox and other PV related query inbox; ensured emails are assigned and processed within 1 working day
- Performed QC for my peer colleague's transcription
- Approved and signed deviations raised related to any error on the data entry
- Processed Risk materials requests within 2 working days at 99% accuracy
- Performed quarterly reconciliation for the products, resolved discrepancies in close collaboration with the pharmacists and distributor.
- Developed several workflows and Standard Operating Procedures (SOP)
- Assisted medical information on monthly response tracking ~ 200 cases per month
- Performed monthly metrics for Lenalidomide and Thalidomide products
- Assisted in audit readiness and scribed the audit findings
- Performed monthly PAF trending metrics for Lenalidomide and Thalidomide products and updated the results to the regional managers promptly
- Supported HCPs via phone/email with the electronic portal system maintenance (ePPP) for PAF entries
- Generated the annual audit report for ídomide products PPP, and submitted to MHRA in a timely manner
- Assisted in reviewing PV agreement records against current Safety Data Exchange Agreements
- Provided training to the relevant employees on existing procedures as well as new SOPs
- Engaged in the development of Risk Management Materials (RMM) and received training on managing artwork processes.
- Actively participated in quarterly Pharmacovigilance System Master File (PSMF) meetings, contributing effectively as required.
- Conducted monthly pharmacovigilance (PV) oversight reporting, presenting findings and insights to the Corporate team.
Pharmacovigilance course
ACI trainings
06.2021 - 09.2021
- Case processing – handled about 50 quality cases, with Naranjo-scale causality assessment
- MedDRA Coding
- Narrative writing – documented the above and reviewed with mentors
- Knowledge of Good Pharmacovigilance Practice (GPvP)
- Knowledge of clinical trial and Good Clinical Practice (GCP)
- Awareness of various Pharmacovigilance guidelines
- Hands-on training with Argus Safety database (ORACLE certified “expert level”)
Extended career break, home maker
02.2019 - 05.2021
- Stay-at-home mum taking care of my elder daughter
- Held casual part-time dance classes for kids and corporate events
- Stuck in India during the COVID-19 pandemic, became a mum a 2nd time and decided to extend my career break
Customer Service Adviser
West Berkshire Council
Newbury, UK
05.2016 - 01.2019
- Responded to over 100 customer calls/face-face on a daily basis and resolved 99% of their cases in the same day, the 1% remainder being escalated
- Been complimented by my supervisor for showing interest to the customers on every conversation/ dedication to learn and improve
- More than 98% of my calls were deemed very good based on internal silent call monitoring
Career break for maternity leave
11.2017 - 11.2018
eClinical Analyst
Zifo Technologies Pvt Ltd
Chennai, India
02.2013 - 09.2013
- Attended to and resolved approximately 900 technical and functional issues, queries and problems via chat - met or exceeded customer satisfaction levels
- Evaluated email requests for different clinical studies related to Viedoc EDC system, escalated to second level support when required and followed up on a regular basis until issues were resolved and proactively kept users informed
- Administered matters related to user management such as account creation and password reset and executed project maintenance in Viedoc and e-novex EDC system
Junior Research Fellow
Sri Ramachandra University
Chennai, India
05.2012 - 01.2013
- Assisted and contributed substantially to the project of identification of common genetic variants among the Indian population associated with cardiovascular diseases
- Initiated recruitment of subjects to the clinical trial, conducted assessments and collated information
- Collected, documented and analysed pedigree information data from about 500 subjects to satisfy the inclusion and exclusion criteria
- Utilised laboratory techniques and performed DNA isolation from the selected test individuals
Education
M.Sc. - Molecular Genetics
University of Leicester
01.2012 - 12.2012
BTech - Biotechnology
Vinayaka Missions University
01.2010 - 12.2010
Skills
- Oracle Argus Safety database
- Viedoc (Electronic Data Capture System)
- ICSR processing and management
- Microsoft Office proficiency
- Narrative writing
- MEDRA Coding
- Good Clinical Practice (GCP)
- Clinical Data Management
- Clinical Trials
- Good Pharmacovigilance Practice (GPvP)
- ICH guidelines
- Regulatory guidelines
Websites
Personal Information
- License: Hold full clean UK License
- Citizenship: UK British Citizen
- Nationality: UK National
Hobbies
- Semi professional dancer
- Singing
- Cooking
Accomplishments
Honored with the "Beyond the Call of Duty" award in 2023 for outstanding performance in managing audit document preparation and maintaining exceptional communication with internal stakeholders, while independently overseeing daily activities during unforeseen team absences.
Certification
Argus database-expert lelvel
Timeline
Pharmacovigilance Officer
Accord UK-Pvt Ltd
01.2022 - 10.2024
Pharmacovigilance course
ACI trainings
06.2021 - 09.2021
Extended career break, home maker
02.2019 - 05.2021
Career break for maternity leave
11.2017 - 11.2018
Customer Service Adviser
West Berkshire Council
05.2016 - 01.2019
eClinical Analyst
Zifo Technologies Pvt Ltd
02.2013 - 09.2013
Junior Research Fellow
Sri Ramachandra University
05.2012 - 01.2013
M.Sc. - Molecular Genetics
University of Leicester
01.2012 - 12.2012
BTech - Biotechnology
Vinayaka Missions University
01.2010 - 12.2010
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