Parul Sharma
Cambridge,ON
Overview
12
12
years of professional experience
Work History
Team Manager
PAREXEL International India Private Limited
03.2019 - 04.2024
- Led a team of healthcare, scientific, and administrative personnel within the pharmacovigilance department
- Ensured the safety and compliance of client-specific projects
- Performed quality checks of ICSR to ensure accuracy and completeness of safety reports by client SOP
- Managing and guiding the team involved in ICSR Processing
- Assisting the project manager in planning work capacities and managing the workload to ensure compliance with client /regulatory timelines
- Involved in Business Continuity Planning and Inspection readiness
Associate Team Manager
PAREXEL International India Private Limited
11.2018 - 02.2019
- Supervised and coordinate various aspects related to drug safety and adverse event reporting
- Responsible for ensuring the timely and accurate processing of patient reports.
Senior Pharmacovigilance Specialist
PAREXEL International India Private Limited
04.2014 - 11.2018
- Conducted comprehensive reviews of adverse event reports for investigational and marketed products
- Served as a lead during audits and inspections, answering questions and providing necessary information.
Pharmacovigilance Analyst
Quantum Solutions India
04.2013 - 03.2014
- Provided pharmacovigilance input to cross-functional teams within the organization
- Provided training to PV personnel for clients from different countries across the Globe on ICSR processing and general PV
Pharmacovigilance Scientist
Quantum Solutions India
12.2011 - 03.2013
- A subject matter expert
- Expertise in management of ICSRs of all case types (including spontaneous, E2B, clinical, and medical devices) intake to data entry to quality review
- Experience in writing narratives for Clinical Study Reports (CSR)
- Expertise in MedDRA coding in accordance with “MedDRA Term Selection: Points To Consider”
- Expertise in managing safety data on various safety databases (AWARE, ARISg and ARGUS)
- Maintaining awareness of global regulatory reporting obligations
- Maintaining a good working knowledge of the safety profile of assigned products, client procedures, and international drug safety regulations including ICH guidelines on safety and efficacy, FDA guidelines, CIOMS, and GVP modules
- Interacting with client personnel to resolve issues related to the processing of ICSRs and responding promptly.
Education
PG Diploma in Health and Social Systems Navigation -
Conestoga College
05.2024
Master's in Human Genomics -
NCHGSR, Panjab University
01.2011
Bachelor's in Bioinformatics (Hon) -
DAV College
01.2009
Class 12 -
Lawrence Public School
01.2005
Class 10 -
Lawrence Public School
01.2003
Skills
- Professional written and verbal communication skills Experienced Global trainer, provided training to pharmacovigilance personnel for clients from different countries across the Globe on maintaining a good working knowledge of the safety profile of assigned products, client procedures, and international drug safety regulations including International Conference for Harmonisation (ICH guidelines) on safety and efficacy, FDA guidelines, CIOMS, and GVP modules for Good clinical Practices Expertise in management of ICSRs of all case types (including spontaneous, E2B, clinical, and medical devices) intake to data entry to quality review Experience in writing narratives for Clinical Study Reports (CSR) Expertise in MedDRA coding in accordance with “MedDRA Term Selection: Points To Consider” Expertise in managing safety data on various safety databases (AWARE, ARISg and ARGUS) Planning work capacities and managing the workload to ensure compliance with client timelines Experience in Business Continuity Planning and Inspection readiness Served as a lead during audits and inspections, answering questions and record management Knowledge of office practices and procedures to provide efficient administrative services Conducted interviews, collecting and analyzing statistical data Provided advice to senior managers and officials, on issues such as health promotion, regulation, standards, and financing Excellent counseling skills using an optimistic approach with 4 years of working with an NGO Expertise in Microsoft Office
Introduction
A dynamic and client-oriented professional. A quick learner, trouble-shooter, enthusiastic, excellent organizational skills, and flexible working style have helped me be successful both as an individual contributor and team manager.
Languages
Fluency in English, Hindi, and Punjabi
Social Work Experience
Nanhe Kadam, Social Worker, 04/01/13, 03/01/19, Volunteered with “Nanhe Kadam” in Chandigarh as a social worker focused on children’s education. Conducted counselling sessions with the parents and educational workshops for children aged 6-12, emphasizing literacy and life skills and. Assisted in organizing after-school tutoring sessions to support students with homework and learning challenges with help of friends and colleagues. Volunteered to teach science at village schools to underprivileged children. Collaborated with teachers to develop engaging lesson plans and educational materials. Involved in fundraising for various requirements of the children apart from education like school supplies, food, clothing, and medical assistance.
Summary Of Experience
- PAREXEL International India Private Limited, Team Manager, 03/01/19, 04/01/24, Led a team of healthcare, scientific, and administrative personnel within the pharmacovigilance department. Ensured the safety and compliance of client-specific projects. Performed quality checks of ICSR to ensure accuracy and completeness of safety reports by client SOP. Managing and guiding the team involved in ICSR Processing. Assisting the project manager in planning work capacities and managing the workload to ensure compliance with client /regulatory timelines. Involved in Business Continuity Planning and Inspection readiness
- PAREXEL International India Private Limited, Associate Team Manager, 11/01/18, 02/01/19, Supervised and coordinate various aspects related to drug safety and adverse event reporting. Responsible for ensuring the timely and accurate processing of patient reports.
- PAREXEL International India Private Limited, Senior Pharmacovigilance Specialist, 04/01/14, 11/01/18, Conducted comprehensive reviews of adverse event reports for investigational and marketed products. Served as a lead during audits and inspections, answering questions and providing necessary information.
- Quantum Solutions India, Pharmacovigilance Analyst, 04/01/13, 03/01/14, Provided pharmacovigilance input to cross-functional teams within the organization. Provided training to PV personnel for clients from different countries across the Globe on ICSR processing and general PV
- Quantum Solutions India, Pharmacovigilance Scientist, 12/01/11, 03/01/13, A subject matter expert. Expertise in management of ICSRs of all case types (including spontaneous, E2B, clinical, and medical devices) intake to data entry to quality review. Experience in writing narratives for Clinical Study Reports (CSR). Expertise in MedDRA coding in accordance with “MedDRA Term Selection: Points To Consider”. Expertise in managing safety data on various safety databases (AWARE, ARISg and ARGUS). Maintaining awareness of global regulatory reporting obligations. Maintaining a good working knowledge of the safety profile of assigned products, client procedures, and international drug safety regulations including ICH guidelines on safety and efficacy, FDA guidelines, CIOMS, and GVP modules. Interacting with client personnel to resolve issues related to the processing of ICSRs and responding promptly.
- Trumac Healthcare India, Researcher, 02/01/10, 12/01/11, Assisted in the development of government health policies. Reviewed relevant literature, conducted interviews, collecting and analyzing statistical data. Provided advice to senior managers and officials, on issues such as health promotion, regulation, standards, and financing. Assisted in the design and implementation of health projects or programs. Responded to external and internal program and policy information requests.
Timeline
Team Manager
PAREXEL International India Private Limited
03.2019 - 04.2024
Associate Team Manager
PAREXEL International India Private Limited
11.2018 - 02.2019
Senior Pharmacovigilance Specialist
PAREXEL International India Private Limited
04.2014 - 11.2018
Pharmacovigilance Analyst
Quantum Solutions India
04.2013 - 03.2014
Pharmacovigilance Scientist
Quantum Solutions India
12.2011 - 03.2013
PG Diploma in Health and Social Systems Navigation -
Conestoga College
Master's in Human Genomics -
NCHGSR, Panjab University
Bachelor's in Bioinformatics (Hon) -
DAV College
Class 12 -
Lawrence Public School
Class 10 -
Lawrence Public School