Maxwell Mascarenhas
Mumbai
Summary
Experienced professional with a strong background in BA-BE studies and pharmacovigilance activities. Results-oriented, with a passion for continuous learning and innovation. Proficient in safety databases. Skilled in problem-solving and optimizing performance. Capable of managing projects and collaborating effectively with teams. Committed to continuous learning and staying current with industry trends to contribute to organizational success.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Assistant II PSS
Fortrea Inc
Mumbai
12.2021 - Current
- Reviewed and assessed adverse event reports for accuracy, completeness and compliance with regulatory requirements.
- Conducted root cause analysis of complex cases involving multiple factors that could have contributed to an adverse event.
- Outlined remediation plans to standardize results to meet compliance regulations.
- Tracked quality metrics associated with pharmacovigilance activities.
- Assessed causality of reported events according to the World Health Organization criteria.
- Evaluated individual cases for appropriate follow-up action including Medical Information inquiries, Field Safety Corrective Actions, and serious adverse event reporting to regulatory authorities worldwide.
- Mentored junior team members on best practices related to daily activities and conducted trainings on standard operating procedures, as well as timely sessions, to provide updates and improve functional competencies.
Safety Science Analyst
Wissen Infotech Pvt. Ltd
Mumbai
12.2020 - 12.2021
- Reviewing and evaluating adverse event reports (AERs) to determine if they meet regulatory reporting requirements.
- Performed medical coding using MedDRA to accurately assign terms to individual cases.
- Maintained database integrity through accurate data entry into the Pharmacovigilance System Database.
- Reviewed and analyzed adverse event reports for accuracy, completeness, and medical relevance.
Junior Officer-Bioanalytical
Panexcell Clinical Labs Pvt. Ltd
Navi-Mumbai
08.2019 - 07.2020
- Maintained records of analytical testing activities and prepared reports for review by senior management personnel.
- Conducted bioanalysis using various techniques to analyze the bioequivalence of generic products.
- Maintained accurate records of test data and reported results to management team.
- Utilized advanced laboratory instruments including mass spectrometers, FTIRs, HPLCs, GCs, pH meters and other analytical tools.
- Analyzed samples using techniques such as spectrophotometry and titration.
- Coordinated multiple projects simultaneously while meeting tight deadlines.
- Reviewed safety regulations before beginning any experiment or task in the lab environment.
Research Associate
Macleods Pharmaceuticals Pvt. Ltd.
Mumbai
06.2017 - 07.2019
- Analysis of biological samples obtained from clinical trial subjects of bioequivalence studies.
- Bio-analytical method development and validation, and use of that method for study sample analysis.
- Operating LC-MS-MS System at analyst level.
- Compilation of raw data of various activities performed.
- Involved in first-to-file bioequivalence studies.
- Assist in audit preparation.
Education
Master of Pharmacy - Quality Assurance
SVKM'S Dr. Bhanuben Nanavati College of Pharmacy
Mumbai, India08-2018
Bachelor of Pharmacy - Pharmaceutical Sciences
St. John Institute of Pharmacy And Research
Palghar, India05-2015
H.S.C -
Thomas Baptista Junior College
Mumbai, India05-2011
S.S.C -
St. Augustine's High School
Maharashtra, India06-2009
Skills
- Flexible and Adaptable
- Active Listening
- Interpersonal Communication
- Good clinical practice
- Audit Assistance
- Reliability
- Attention to Detail
Languages
Marathi
First Language
English
Proficient (C2)
C2
Hindi
Proficient (C2)
C2
Certification
- Advanced Post Graduate Diploma in Pharmaceutical Business Analytics.
Timeline
Assistant II PSS
Fortrea Inc
12.2021 - Current
Safety Science Analyst
Wissen Infotech Pvt. Ltd
12.2020 - 12.2021
Junior Officer-Bioanalytical
Panexcell Clinical Labs Pvt. Ltd
08.2019 - 07.2020
Research Associate
Macleods Pharmaceuticals Pvt. Ltd.
06.2017 - 07.2019
Master of Pharmacy - Quality Assurance
SVKM'S Dr. Bhanuben Nanavati College of Pharmacy
Bachelor of Pharmacy - Pharmaceutical Sciences
St. John Institute of Pharmacy And Research
H.S.C -
Thomas Baptista Junior College
S.S.C -
St. Augustine's High School
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