Simi Jose
Lead associate-Regulatory Affairs
Bangalore
Summary
Overall 7.5 years of Regulatory experience including 2.5 years of hands-on experience in Veeva vault data management and enrichment. 5+ years of experience in XEVMPD, and Web trader, EVweb (Article 57) for evaluation and submissions of medicinal product data. Experience in regulatory site screening for signals and recommendations from regulatory bodies in line with SPC or PI and recommend label updates for the same.
Overview
20
20
years of professional experience
1
1
Language
Work History
Lead Associate-Operations
Genpact India Pvt.Ltd.
2 2022 - Current
- Data migration activities under the RIMS group
- As per client requirement doing data enrichment in the object intake form which is shared by the client as per Veeva naming conventions and migration in Veeva database
- Creating applications, registrations, submissions, regulatory objectives, commitments, packaging, etc
- Data mining and collection from metadata which are provided by the client through SharePoint.
Safety submission Specialist-Associate
Kinapse India Scientific Services Pvt. Ltd.
03.2021 - 09.2021
- Worked on the EMA XEVMPD project on the Article 57 database
- Evaluation for medicinal products in web trader and make sure they follow the regulations, guidelines, and criteria according to the SPC or PIL respectively.
Drug Safety Associate-Pharmacovigilance
Norwich Clinical Services Pvt Ltd
02.2017 - 03.2021
- Data entry and Quality checking of XEVMPD filings for medicinal products
- Upon receipt of notification check the correctness of data, tracking, data entry, follow up for missing information, timely submissions, etc
- Initial search and assessment of findings from weekly regulatory site search activities and proposing recommendations for client product labels
- Checking for listedness of adverse events/reactions or signals in the labels/RSIs
- Responsible for legislation screening and impact analysis related to the update on PV guidelines
- Responsible for the safety label update (variations) and maintaining the safety label database
- Responsible for the preparation of CCSIs
- Compliance tracking for the ongoing safety issues and also responsible for recommending the actions needs to be taken by the MAH on these issues.
Senior Executive QC
Norwich clinical Services Pvt Ltd
01.2012 - 12.2013
- 100% review of chromatograms of Method Development, Method Validation, and Bio studies
- Review of all raw data forms.log book entries as per department SOPs
- Ensure that all types of equipment are calibrated as per schedule
- Ensure that GLPs are followed as documented in SOPs
- Coordinate with the manager or HOD for any issues/Audit findings regarding the projects handled
- Review and plan procurement of columns and working standards for various projects
- Maintain an updated list of columns and working standards available.
Senior technical support executive(TSE)
Lotus Labs Pvt Ltd
04.2006 - 03.2009
- Same as above Senior Executive QC role
Pharmacist
St. Johns Medical College and Hospital Bangalore
07.2004 - 04.2006
- Worked as a registered pharmacist, dispensing medicines, billing, ordering, and stock checking.
Education
Skills
RIMS-Data migration activities in Veeva and hands-on experience in data management, enrichment, and migration from metadata/track-wise depending on the requirement From the product family and variants create applications, registration, submission, regulatory objective, etc IDMP-checking of organization details in OMS(SPOR) for location ID, Organisation ID, address, and postal code as per the project requirements XEVMPD evaluation and submissions of medicinal product data in Webtrader -Data management, data entry, QC, tracking the notification, Follow-up for missing details, communication with the client for updates, etc
Languages
English,Malayalam,Hindi,Tamil
Timeline
Safety submission Specialist-Associate
Kinapse India Scientific Services Pvt. Ltd.
03.2021 - 09.2021
Drug Safety Associate-Pharmacovigilance
Norwich Clinical Services Pvt Ltd
02.2017 - 03.2021
Senior Executive QC
Norwich clinical Services Pvt Ltd
01.2012 - 12.2013
Senior technical support executive(TSE)
Lotus Labs Pvt Ltd
04.2006 - 03.2009
Pharmacist
St. Johns Medical College and Hospital Bangalore
07.2004 - 04.2006
Lead Associate-Operations
Genpact India Pvt.Ltd.
2 2022 - Current
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