Mounica Sattu
Senior CV Specialist / Deputy QPPV
Aylesbury
Summary
Experienced pharmacovigilance professional with a diverse background in case management, vendor management, emergency safety issues, regulatory intelligence, health authority communications, aggregate report submissions, and quality and compliance management.
Overview
11
11
years of professional experience
Work History
Senior Pharmacovigilance Specialist / Deputy QPPV
Organon Pharma UK Limited
2 2021 - Current
- Responsible for all PV activities at country level and serve as the PV contact with local stakeholders, headquarters (HQ) and the local health authority, when required
- Act as local subject matter expert (SME) and collaborating with colleagues to ensure compliance with local laws and regulations, including backing up colleagues and adjusting schedules such that there is no gap in adverse event reporting and safety oversight.
PV Specialist
MSD
05.2018 - 01.2021
- Responsible for all PV activities and collaborates with colleagues to ensure compliance with local laws and regulations, including backing up colleagues and adjusting schedules such that there is no gap in adverse event reporting and drug safety oversight
- Responsible for other activities (as delegated/assigned by their manager) which may include but are not limited to review of local PV agreements, local due diligence activities, participation in audits and inspections and related readiness activities, review of local initiatives for compliance with PV requirements, authoring/reviewing SOPs, training, communication of safety issues, developing product registration plans and strategies.
PV Associate
PharSafer Associates Ltd
06.2017 - 02.2018
- Performing data entry for literature, spontaneous and regulatory cases
- Performing initial triage for the case
- Determining the causality of the cases
- Performing quality check for cases
- Adhering to the reporting timelines and submitting the cases.
Safety specialist
Parexel International / India - Hyderabad
10.2015 - 02.2016
- Performing data entry for, spontaneous cases in Arisg
- Performing initial triage for the case
- Determining the of the causality of cases
- Performing quality check for cases
- Adhering to the reporting timelines and submitting the cases.
Drug safety specialist
ICON Clinical Research / India - Chennai
06.2013 - 10.2015
- Evaluating and processing serious and non-serious ADRs from different sources including clinical trials, spontaneous, authority, compassionate use, literature cases and other medically related information per study specific procedures using database and compiling narrative for medical assessment
- Reviewing case criteria to determine the appropriate workflow for case processing
- Checking for completeness and accuracy of data entered in various fields
- Working as a Subject matter Expert (SME) in Pharmacovigilance Quality team
- Documentation of serious adverse event processing and performing safety review of adverse event report of company products
- Complaint reports based on corporate and global regulations and guidelines for submission to regulators World-Wide
- Adhere to service-level agreements as specified by client in a high-throughput environment
- Responsible for identifying duplicate/invalid ICSRs in Argus and handling as per relevant SOP
- Responsible for migrating data from Arisg to Argus database for legacy cases.
Education
Maters in pharmacology -
Care colleague of Pharmacy / Warangal-India
01.2011 -
Bachelors in pharmacy - undefined
Blue bird's college of pharmacy /Warangal-India
01.2007 - undefined
Skills
Resource Allocation
Emergency Response
Quality Assessment
Technical communication
Management collaboration
Teamwork and Collaboration
Decision-Making
Problem-Solving
Time Management
Multitasking Abilities
Self Motivation
Effective Communication
Versiondate
31-August-2024
Training
International certification as Drug Safety Associate (pharmacovigilance, regulatory reporting), International academy of clinical research (IAOCR), 2015
Timeline
PV Specialist
MSD
05.2018 - 01.2021
PV Associate
PharSafer Associates Ltd
06.2017 - 02.2018
Safety specialist
Parexel International / India - Hyderabad
10.2015 - 02.2016
Drug safety specialist
ICON Clinical Research / India - Chennai
06.2013 - 10.2015
Maters in pharmacology -
Care colleague of Pharmacy / Warangal-India
01.2011 -
Bachelors in pharmacy - undefined
Blue bird's college of pharmacy /Warangal-India
01.2007 - undefined
Senior Pharmacovigilance Specialist / Deputy QPPV
Organon Pharma UK Limited
2 2021 - Current
Similar Profiles
ERIKA SANOJAERIKA SANOJA
Administrator at Curium Pharma UK LtdAdministrator at Curium Pharma UK Ltd
Hanson SoHanson So
Solutions Planning and Business Development at Canon (UK) Limited - Solutions Planning / UK & IrelandSolutions Planning and Business Development at Canon (UK) Limited - Solutions Planning / UK & Ireland
SAI KRISHNA CHAITANYA SAI KRISHNA CHAITANYA null
INTERNATIONAL LOGISTICS OPERATIONS/ANALYST at Aurobindo Pharma LimitedINTERNATIONAL LOGISTICS OPERATIONS/ANALYST at Aurobindo Pharma Limited
Jameelah BhanaJameelah Bhana
Post-Internship Activities at NAPost-Internship Activities at NA
Vyshnavi MuvvaVyshnavi Muvva
Customer Service Representative at Coversure InsuranceCustomer Service Representative at Coversure Insurance