Mohit Vashistha
Ghaziabad
Summary
Seasoned pharmacovigilance professional with over 16 years of experience in pharmacovigilance and quality assurance. Certified ISO 9001 lead auditor with expertise in managing pharmacovigilance departments and serving as a global QPPV. Proven track record in compliance management and conducting internal and external audits to ensure adherence to regulatory standards.
Overview
16
16
years of professional experience
1
1
Certification
Work History
AGM - Pharmacovigilance
Amarant Lifesciences Pvt Ltd
Noida
07.2025 - Current
- Directed pharmacovigilance operations for EU clients, ensuring compliance with regulatory requirements.
- Delivered client goals through strategic oversight and execution, ensuring alignment with regulatory standards.
- Led continuous improvement initiatives that enhanced drug safety and minimized risks.
- Defined pharmacovigilance scope and objectives, developing project plans and monitoring progress.
- Managed client and stakeholder engagement to enhance communication and collaboration on pharmacovigilance projects.
- Facilitated cross-functional collaboration to streamline processes and achieve improved drug safety outcomes.
- Supported audits and inspections to ensure quality standards compliance and identify improvements.
- Implemented CAPAs to address audit findings, promoting process optimization.
AGM - Pharmacovigilance
Kusum Healthcare Pvt Ltd
New Delhi
01.2023 - 07.2025
- Acted as Global QPPV, facilitating seamless pharmacovigilance system operations at Kusum Healthcare Pvt Ltd.
- Directed pharmacovigilance department, ensuring compliance with regulations and operational excellence.
- Managed Pharmacovigilance System Master File (PSMF), upholding regulatory standards and ensuring accurate documentation.
- Supervised daily pharmacovigilance activities for Kusum's product portfolio, enhancing safety monitoring and reporting.
- Conducted vendor and subcontractor audits to ensure compliance with GVP guidelines.
Senior Manager (Level-2), Pharmacovigilance
PharmaLex India Pvt Ltd
Noida
04.2022 - 01.2023
- Led multiple PV case processing projects
- Coordinated Pharmacovigilance activities, supporting PV consulting projects with strategic direction.
- Conducted audits of subcontractor PV activities for compliance with GVP guidelines.
- Cultivated client relationships to enhance satisfaction and drive retention.
Senior Manager - Pharmacovigilance
PharmaLex India Pvt Ltd
Noida
05.2021 - 04.2022
- Led PV project with over 200 associates, ensuring operational efficiency and effective coordination.
- Provided strategic input and subject matter expertise for Safety Services in planning and setup of projects, covering costing, budgeting, resourcing, workflow, and process design.
- Conducted audits of PV activities by subcontractors to ensure compliance with GVP guidelines.
Senior Manager - Quality Assurance
PharmaLex India Pvt Ltd
New Delhi
04.2019 - 04.2021
- Executed external and internal PV audits per GVP guidelines to assess adherence to regulatory standards
- Conducted vendor qualification audits to ensure compliance with quality standards
- Managed CAPA, non-conformity, and complaint processes to effectively resolve quality issues and enhance overall quality system
- Conducted quality assurance activities and monitored quality-related aspects to ensure compliance and improve product integrity
Manager - Quality Assurance
PharmaLex India Pvt Ltd
New Delhi
11.2017 - 03.2019
- Conducted external and internal audits to ensure adherence to GVP guidelines and identify areas for improvement.
- Managed CAPA investigations and resolved non-conformities to maintain compliance with quality standards and enhance product integrity.
- Facilitated management review meetings and executed vendor qualification audits to assess quality performance and drive supplier accountability.
Manager - Pharmacovigilance
PharmaLex India Pvt Ltd
New Delhi
04.2016 - 11.2017
- Project Manager for Pharmacovigilance projects.
- Ensured regulatory compliance.
- Coordinated cross-functional teams for effective communication and collaboration.
- Analyzed data trends to identify potential safety signals and risks.
Jr. Medical Advisor - PV
YES Regulatory Healthcare Services India Pvt Ltd
New Delhi
10.2014 - 03.2016
- Reviewed and analyzed individual case safety reports (ICSRs).
- Advised healthcare teams on regulatory compliance and best practices.
- Reviewed clinical trial protocols for adherence to regulatory standards.
- Collaborated with cross-functional teams to develop strategic healthcare initiatives.
Senior Associate - PV
Kinapse India Scientific Services Pvt Ltd
Gurugram
09.2011 - 10.2014
- Conducted quality assurance reviews of ICSRs on EudraVigilance to ensure compliance with regulatory standards.
Associate - Pharmacovigilance
Wipro Limited
Greater Noida
12.2009 - 09.2011
- Data Entry and QC of ICSRs
Education
PG Diploma - Advanced Clinical Research, Pharmacovigilance
Institute of Clinical Research
New Delhi08-2009
B. Pharm - Pharmacy
ITS College of Pharmacy
Ghaziabad, UP05-2008
Skills
- Leadership and project management
- Operational excellence
- Risk assessment and management
- Regulatory compliance
- Stakeholder engagement
- Pharmacovigilance agreements
Certification
- ISO 9001:2015 Lead Auditor
- Lean Six Sigma Yellow Belt
- Project Management Essentials
Languages
First Language, C2 Proficient
Extracurricular Activities
Volunteer, Robin Hood Army, Ghaziabad (Delhi-NCR). Helping to serve the extra food left out from Restaurants/Functions to the needy ones Rider, Road Thrill - Ghaziabad Chapter, spreading awareness on cleanliness on earth while riding to different places
Languages
English
Proficient (C2)
C2
Hindi
Native
Native
Timeline
AGM - Pharmacovigilance
Amarant Lifesciences Pvt Ltd
07.2025 - Current
AGM - Pharmacovigilance
Kusum Healthcare Pvt Ltd
01.2023 - 07.2025
Senior Manager (Level-2), Pharmacovigilance
PharmaLex India Pvt Ltd
04.2022 - 01.2023
Senior Manager - Pharmacovigilance
PharmaLex India Pvt Ltd
05.2021 - 04.2022
Senior Manager - Quality Assurance
PharmaLex India Pvt Ltd
04.2019 - 04.2021
Manager - Quality Assurance
PharmaLex India Pvt Ltd
11.2017 - 03.2019
Manager - Pharmacovigilance
PharmaLex India Pvt Ltd
04.2016 - 11.2017
Jr. Medical Advisor - PV
YES Regulatory Healthcare Services India Pvt Ltd
10.2014 - 03.2016
Senior Associate - PV
Kinapse India Scientific Services Pvt Ltd
09.2011 - 10.2014
Associate - Pharmacovigilance
Wipro Limited
12.2009 - 09.2011
PG Diploma - Advanced Clinical Research, Pharmacovigilance
Institute of Clinical Research
B. Pharm - Pharmacy
ITS College of Pharmacy