Arisg
Rekha Badgujar
Senior process associate (Pharmacovigilance scientist)
Thane,Maharashtra
Summary
Experienced pharmacovigilance professional with a strong background in managing drug safety data and a solid understanding of SAP MM (Material Management) processes. Proficient in implementing SAP solutions to optimize inventory management, procurement, and compliance in the pharmaceutical industry. Committed to leveraging expertise in pharmacovigilance and SAP MM to enhance operational efficiency and ensure safety within healthcare and pharmaceutical organizations.
Overview
11
11
years of professional experience
4
4
Certifications
Work History
Senior Pharmacovigilance Specialist
Tata Consultancy Service
Thane
06.2014 - Current
- Contributed to the development of standardized operating procedures, ensuring a consistent approach to pharmacovigilance tasks across the organization.
- Assisted in the preparation of periodic safety update reports, providing comprehensive reviews of product safety data.
- Contributed to quality improvement initiatives within the department, driving continuous enhancements to pharmacovigilance operations.
- Supported audits and inspections by providing necessary documentation and showcasing adherence to established pharmacovigilance procedures.
- Maintained up-to-date knowledge of global regulations and guidelines related to pharmacovigilance practices.
- Mentored junior staff members, enhancing their skills and knowledge within the field of pharmacovigilance.
- Enhanced drug safety monitoring by conducting comprehensive case analyses and assessments.
- Proactively addressed potential discrepancies in adverse event reporting through thorough investigation and resolution efforts.
- Managed timelines effectively, ensuring timely completion of critical deliverables within the realm of pharmacovigilance responsibilities.
- Supported inspections, visits and audits as well as CAPAs management.
- Trained staff and updated training documents to meet regulations and standards.
- Read scientific literature and bibliographic sources.
Education
Master of Pharmacy - Pharmacy
H.R.Patel Institute of Pharmaceutical Education
Shirpur 04.2001 - 2013.07
Bachelor of Pharmacy - Pharmacy
H.R.Patel Institute of Pharmaceutical Education
04.2001 - 2011.06
Skills
- Pharmacovigilance (PV): Adverse event reporting , Signal detection, Risk Management, Regulatory Compliance (EMA, ICH, TGA guidelines), Safety data Analysis
- SAP MM (Material management): SAP S/4 HANA MM, procurement, Inventory Management, SAP integration, Invoice verification, Request for quotation, Stock transfers, Split valuation, Material requirements planning, Vendor evaluation, SAP MM configuration, Release strategy, Purchasing processes, Batch management, Master data management Document management, Purchase orders, Physical inventory, Subcontracting process, Scheduling agreements, External services management, Storage location management, Purchase requisitions, Material valuation
Certification
Pharmaceutical Industry Pharmacovigilance and Drug Safety
Software
LSMV
SAP MM
Declaration
I hereby declare that the information furnished above is true to the best of my knowledge
Timeline
Pharmaceutical Industry Pharmacovigilance and Drug Safety
06-2024
Artificial Intelligence in Pharmacovigilance
05-2024
Pharmacovigilance Audits and Inspections
04-2024
SAP MM S4 HANA (Material Management)
02-2024
Senior Pharmacovigilance Specialist
Tata Consultancy Service
06.2014 - Current
Master of Pharmacy - Pharmacy
H.R.Patel Institute of Pharmaceutical Education
04.2001 - 2013.07
Bachelor of Pharmacy - Pharmacy
H.R.Patel Institute of Pharmaceutical Education
04.2001 - 2011.06
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