Saurabh Srivastav
Noida
Summary
Currently serving as Assistant Manager in Pharmacovigilance at Fresenius Kabi, I bring a methodical and evidence-based approach to regulatory compliance and safety operations. My expertise spans database governance, workflow optimization, and cross-functional coordination—ensuring both regulatory alignment and enhanced pharmacovigilance operations.
Overview
12
12
years of professional experience
Work History
Assistant Manager
Fresenius Kabi
Gurugram
06.2023 - Current
- Managed pharmacovigilance team for ICSR reporting to global regulatory agencies.
- Oversaw daily workflow of adverse events from spontaneous reports, health authorities, and literature.
- Ensured compliance with safety regulations and company policies without exception.
- Conducted regular performance reviews to identify employee improvement areas.
- Coordinated interdepartmental efforts for seamless operational flow.
- Maintained current knowledge of company products and services to enhance decision-making.
Assistant Manager
Tata Consultancy Services
Noida
11.2021 - 06.2023
- Facilitated management of literature and legal patient case reports for ICSR teams.
- Streamlined daily workflow of literature reports across multiple product categories.
- Ensured compliance with safety regulations and company policies throughout all processes.
Assistant Manager
APCER Life Sciences
New Delhi
05.2021 - 11.2021
- Supported pharmacovigilance operations for ICSR reporting to USFDA.
- Processed daily influx of incoming case reports, including literature searches and full-text procurement.
- Managed case distribution workload for incoming reports from business partners.
- Tracked case reports for timely sharing per safety data exchange agreements.
- Handled local vendor communications for literature monitoring under EMA regulation.
- Engaged with customers to gather insights into needs and expectations.
Team Lead
APCER Life Sciences
New Delhi
04.2019 - 04.2021
- Facilitated pharmacovigilance operations for literature monitoring involving six clients.
- Conducted reviews and categorizations of individual case safety reports (ICSRs) for US FDA submissions.
- Ensured training compliance and conducted performance appraisals for team members.
- Oversaw literature monitoring processes, including full text article procurement and reconciliations.
- Resolved customer complaints and queries swiftly to maintain service standards.
- Conducted performance appraisals for team members, providing feedback and identifying areas of improvement.
- Resolved escalated customer complaints or queries promptly and efficiently.
Senior Pharmacovigilance Associate
APCER Life Sciences
New Delhi
04.2017 - 03.2019
- Developed targeted search strategies for drugs and associated adverse events.
- Evaluated adverse drug reaction reports to establish causality.
- Conducted thorough data extraction from Embase and PubMed sources.
- Reviewed patient medical histories and lab results to identify medication-related risks.
- Performed quality assurance checks on case processing activities for consistency.
- Analyzed extracted data to draw actionable conclusions.
- Executed literature searches to uncover safety signals for drug classes.
- Ensured accuracy and reliability of information through rigorous quality assessments.
Pharmacovigilance Associate
APCER Life Sciences
New Delhi
06.2015 - 03.2017
- Conducted primary review of literature searches and shared results with client teams for ICSR reporting.
- Executed daily runs and exports of literature searches from Embase to maintain up-to-date data.
- Assisted in preparing training materials focused on pharmacovigilance best practices.
- Reviewed adverse drug reaction reports from healthcare professionals and patients to evaluate causality.
Project Assistant
CSIR-CIMAP
Lucknow
02.2013 - 05.2015
- Facilitated development, stability testing, and pre-clinical evaluation of topical herbal formulations.
- Organized and maintained project documents and records.
- Assisted with coordination of daily activities for projects.
Education
M. Pharm - Pharmacy
Teerthanker Mahaveer University
Moradabad, U.P.05-2011
B. Pharm - Pharmacy
Integral University
Lucknow, U.P.07-2008
Intermediate Examination - Science
Vardhman Convent Higher Secondary School
01.2004
High School Examination - Science
Fatima Convent Higher Secondary School
05-2001
Skills
- PV Safety Database management
- Data analysis
- Regulatory compliance
- Team management
- Process optimization
- Resource allocation
- Employee performance evaluation
- Orientation and training
- Microsoft office expertise
- Customer service
- Embase expertise
- AI & Language Models: ChatGPT, Microsoft Co-Pilot, Google Gemini, Google Notebook LM, Perplexity
Languages
- Hindi
- English
Awards
Recipient of Silver Medal in Masters
Publications
- Achyranthes aspera-An important medicinal plant: A review, Saurabh Srivastav, Pradeep Singh, Garima Mishra, K. K. Jha, R. L. Khosa, Journal of Natural Products & Plant resources, 2011, 1, 1-14
- Diuretic activity of whole plant extract of Achyranthes aspera Linn, Saurabh Srivastav, Pradeep Singh, K. K. Jha, Garima Mishra, Shruti Srivastava, M. S. Karchuli, R. L. Khosa, European Journal of Experimental Biology, 2011, 1, 97-102
- Anti-inflammatory, analgesic and antipyretic potential of aerial parts of Costus speciosus, Shruti Srivastava, Pradeep Singh, K. K. Jha, Garima Mishra, Saurabh Srivastav, R. L. Khosa, Indian Journal of Pharmaceutical Sciences, 2013, 75, 1, 83-88
- Pharmacognostical study and establishment of quality parameters of aerial parts of Costus speciosus a well-known tropical folklore medicine, Pradeep Singh, Ratan Lal Khosa, Shruti Srivastava, Garima Mishra, Keshri Kishor Jha, Saurabh Srivastav, Sangeeta, Ramesh Kumar Verma, Mohd Adil Tahseen, Asian Pacific Journal of Tropical Biomedicine, 2014, 4, 486-491
References
- Dr. Pradeep Singh, Professor, Debre Tabor University, Ethiopia, pradeep_2682@yahoo.co.in
- Binoy Sharma, Vice President, APCER Life Sciences, Bsharma1685@gmail.com, 9711845531
- Dr. Priyam Sinha, Research Associate, Dr. Reddy's Laboratories, 4u.Priyam@gmail.com, +91 9625384450, +91 9415308067
- Dr. Rakshit Sehgal, Associate Medical Manager, Labcorp Drug Development, +91 8826686903
Additional Information
Water conservation, Green environment, Field of Technology, Music, Cricket and Soccer
Disclaimer
I hereby declare that all the information given above is true to the best of my knowledge and belief.
Timeline
Assistant Manager
Fresenius Kabi
06.2023 - Current
Assistant Manager
Tata Consultancy Services
11.2021 - 06.2023
Assistant Manager
APCER Life Sciences
05.2021 - 11.2021
Team Lead
APCER Life Sciences
04.2019 - 04.2021
Senior Pharmacovigilance Associate
APCER Life Sciences
04.2017 - 03.2019
Pharmacovigilance Associate
APCER Life Sciences
06.2015 - 03.2017
Project Assistant
CSIR-CIMAP
02.2013 - 05.2015
M. Pharm - Pharmacy
Teerthanker Mahaveer University
B. Pharm - Pharmacy
Integral University
Intermediate Examination - Science
Vardhman Convent Higher Secondary School
High School Examination - Science
Fatima Convent Higher Secondary School
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