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Sharad Patel

@sharadpatel1

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Experienced Manager in Global Pharmacovigilance with strong leadership skills.

India

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What I'm looking for

I seek a role that fosters professional growth and values compliance and quality in pharmacovigilance.

I am a seasoned pharmacovigilance professional with over a decade of experience in managing end-to-end pharmacovigilance activities. Currently, I serve as the Manager of Global PV Operations at Glenmark Pharmaceuticals, where I oversee vendor management and ensure compliance across 113 countries. My role involves meticulous quality management, regulatory intelligence assessments, and authoring aggregate reports, which have significantly contributed to the organization's operational excellence.

Throughout my career, I have demonstrated strong leadership in managing diverse teams, with a focus on project planning and people management. My previous roles at Bioclinica and Cognizant Technology Solutions have equipped me with the skills to handle large teams and complex projects effectively. I take pride in my ability to liaise with various stakeholders, ensuring seamless communication and compliance with regulatory standards.

Experience

Work history, roles, and key accomplishments

Current

Manager Global Pharmacovigilance

Current

Glenmark Pharmaceuticals Ltd

Oct 2020 - Present (4 years 8 months)

Currently managing global pharmacovigilance operations, overseeing vendor management and compliance across 113 countries. Responsible for quality management, audits, and regulatory intelligence assessments. Engaged in authoring aggregate reports and managing in-house PV activities.

Vendor Management Quality Assurance Regulatory Compliance Audit Project Management Data Analysis Argus Capacity Planning

Deputy Project Manager

Bioclinica (Qinesca)

Jan 2019 - Sep 2020 (1 year 8 months)

Led a team of 44 FTEs in managing pharmacovigilance projects, focusing on case processing, quality management, and workflow management. Responsible for recruitment and attrition management.

Project Management Team Leadership Quality Management Workflow Management SOP Development Resource Management Recruitment

Team Manager

Cognizant Technology Solutions

May 2016 - Dec 2018 (2 years 7 months)

Managed a team of 120 FTEs, focusing on case prioritization, performance management, and driving SLAs. Responsible for customer handling and governance meetings.

Team Management Performance Management SLA Management Quality Assurance Data Analysis Capacity Planning

Sr. Drug Safety Associate

Inventive Health International Pharma (Syneos)

Nov 2014 - May 2016 (1 year 6 months)

Conducted quality reviews of Individual Case Safety Reports (ICSRs) ensuring compliance with regulatory standards and internal protocols.

Quality ICSR Processing Regulatory Compliance Data Analysis Risk Management Reporting

Data Analyst PV

Cognizant Technology Solutions

May 2012 - Nov 2014 (2 years 6 months)

Performed data entry and processing of ICSRs in pharmacovigilance, ensuring accuracy and compliance with safety regulations.

Data Entry ICSR Processing Quality Assurance Compliance Data Analysis Reporting Risk Management Database Management

Data Analyst

Tata Consultancy Services (TCS)

Aug 2009 - May 2012 (2 years 9 months)

Responsible for data entry of ICSRs in a cardiology safety database, ensuring data integrity and compliance with pharmacovigilance standards.

Data Entry ICSR Processing Compliance Quality Assurance Data Management Reporting Risk Management Database Management

Education

Degrees, certifications, and relevant coursework

Simplilearn

Workshop, Project Management

2019 - 2019

Completed a 4-day workshop on Project Management Professional (PMP), enhancing skills in project management methodologies and best practices.

Academy for Clinical Excellence, BCP

PG Diploma, Clinical Research

2007 - 2009

Grade: 1st Class

Completed a Post Graduate Diploma in Clinical Research, focusing on the principles and practices of clinical research, regulatory requirements, and ethical considerations in clinical trials.