Manoj Singh
Manager-Pharmacovigilance
Kolkata,WB
Summary
Seasoned professional and accomplished leader with 15+ years of expertise in Pharmacovigilance, Regulatory domains and extensive experience in the Life Sciences, Pharma, and Medical Device. Skilled in leadership, account management, and driving organizational growth through strategic planning and operational excellence. Proven expertise in managing patient safety, compliance, and global regulatory processes while building high-performing teams and delivering impactful results.
Experienced with leading large-scale delivery projects and coordinating cross-functional teams to achieve objectives. Utilizes strategic planning and resource management to drive project success. Track record of fostering team collaboration and maintaining high client satisfaction.
Overview
18
18
years of professional experience
6
6
years of post-secondary education
5
5
Certifications
Work History
Account Delivery Head (Manager)-PV Operations
Wipro Limited
04.2020 - Current
- Accountable for project management, including recruitment, training, mentoring, and performance appraisals, fostering a high-performance culture
- Developed and executed comprehensive project management strategies for pharmacovigilance end to end project consistently achieving significant profit margin
- Oversaw budget forecasting and managed profit and loss (P&L) accounts, drive profitability and support strategic decision-making
- Collaborated on solutioning, RFP responses, and bid management to support business development initiatives
- Streamlined project management and service delivery, enhancing overall productivity and effectiveness
- Led hybrid and remote teams across diverse regions, promoting collaboration and driving results
- Spearheaded six sigma initiative focused on improving Average Handling Time and reducing costs, significantly boosting profit margins
- Designed comprehensive dashboards for customer and management reviews, ensuring effective communication with executive leadership and teams
- Lead service delivery review meetings and managed customer escalations, ensuring timely resolution and satisfaction
- Implemented ongoing process improvements to deliver enhanced business value and service quality to clients
- Ensured strict adherence to quality standards and regulatory requirements, maintaining operational excellence
- Dynamically driving process quality improvement initiatives
- SME in the Pharmacovigilance (PV) domain, facilitating effective RFI/RFP responses
- Played a pivotal role in internal and external audits and regulatory inspections, ensuring compliance and operational integrity
Team Manager-Pharmacovigilance
Cognizant Technology Solutions Ltd.
10.2016 - 03.2020
- Responsible for wholesome timely and quality metrics, training, mentoring, and performance appraisal for assigned tower and team
- Managed compliance with global and local pharmacovigilance regulations as per business need
- Conducted high-level negotiations defining the account performance metrics
- Ensured project compliance with client SOPs, maintaining regulatory requirements
- Account level revenue performance management (P&L and ROI)
Team Leader-Pharmacovigilance
Cognizant Technology Solutions Ltd.
07.2013 - 09.2016
- Work allocation and prioritization based upon internal and reporting turnaround time
- Accountable for daily reception, registration, and completion of ICSR with high quality for submission to health authorities and partners
- Daily dashboard on SLA TAT, productivity and utilization for internal and external stakeholders
- Facilitated performance reviews and created training plans for quality improvement
- Designed on-the-job training program for new hires
- Prepared and maintained project management related documents as per ISO 9001-2015
- Implemented an efficient query and feedback system
Data Analyst-Pharmacovigilance
Cognizant Technology Solutions Ltd.
09.2011 - 07.2013
- ICSR processing and creation of follow-up request for additional/missing information
- Suspect product coding, adverse events coding (MedDRA), listedness, and causality assessments, along with narrative writing
- Final quality check and AOSE review, if applicable
- SME and Process trainer for post-marketing case processing
Junior Research Executive
GVK Bioscience Pvt Ltd
08.2009 - 08.2011
- Conducted comprehensive health outcome assessments and performed pharmacometrics data analysis to inform decision-making
- Executed thorough literature searches and reviews to identify and evaluate relevant articles
- Assessed literature for adverse events and conducted detailed medical reviews of articles to ensure accuracy and compliance
Production Executive
BACFO Pharmaceutical India Ltd
09.2006 - 10.2007
- Hands-on experience as Manufacturing Chemist/Production Executive, with expertise in SOPs and GMP to ensure compliance and efficiency
- Implemented and monitored Standard Operating Procedures (SOPs) to streamline processes and ensure consistent product quality
- Ensured strict adherence to Good Manufacturing Practices (GMP), maintaining compliance with regulatory standards and company policies
- Collaborated with cross-functional teams to address production challenges, optimize workflows, and enhance operational efficiency
Education
Master of Pharmacy (M. Pharm) - Pharmacy Practice
National Institute of Pharmaceutical Education and Research (NIPER)
01.2007 - 01.2009
Bachelor of Pharmacy (B. Pharm) - undefined
Uttar Pradesh Technical University (UPTU)
01.2002 - 01.2006
Skills
Pharmacovigilance
Certification
WPMP (Wipro Project Management Professional), Wipro Limited
Timeline
Account Delivery Head (Manager)-PV Operations
Wipro Limited
04.2020 - Current
Team Manager-Pharmacovigilance
Cognizant Technology Solutions Ltd.
10.2016 - 03.2020
Team Leader-Pharmacovigilance
Cognizant Technology Solutions Ltd.
07.2013 - 09.2016
Data Analyst-Pharmacovigilance
Cognizant Technology Solutions Ltd.
09.2011 - 07.2013
Junior Research Executive
GVK Bioscience Pvt Ltd
08.2009 - 08.2011
Master of Pharmacy (M. Pharm) - Pharmacy Practice
National Institute of Pharmaceutical Education and Research (NIPER)
01.2007 - 01.2009
Production Executive
BACFO Pharmaceutical India Ltd
09.2006 - 10.2007
Bachelor of Pharmacy (B. Pharm) - undefined
Uttar Pradesh Technical University (UPTU)
01.2002 - 01.2006
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