TANISHA SHARDA
Toronto
Summary
More than one year of experience in pharmacovigilance including triage, initiation, and medical regulatory assessment of Individual Case Safety Reports (ICSRs). Experienced in managing ICSRs of various case types (clinical trial, spontaneous, solicited programs and literature cases). Familiar with international drug safety regulations (including ICH guidelines on safety and efficacy, US FDA guidelines, CIOMS, New EU PV legislation). Worked in three team simultaneously. Familiar with various project management practices and MS project and hold CAPM certification. Looking forward to expand my learning and how to make a positive impact on a global scale.
Overview
2
2
years of professional experience
1
1
Certification
Work History
Drug Safety Associate
Parexel International Limited
11.2021 - 06.2023
- Generated reports detailing findings and recommendations.
- Leveraged strong interpersonal skills to build relationships with stakeholders across departments, fostering collaboration in support of winning proposals.
- Provided reporting for forecast analysis and ad-hoc reporting in support of decision-making.
- Collected, arranged, and input information into database system.
- Follow international drug safety regulations (ICH, FDA, CIOMS, EU PV)
- Collaborated with cross-functional teams to gather technical, financial, and strategic information for comprehensive proposals.
- Maintain knowledge of AE safety, Reference Safety Information and guidelines
Education
Graduate Certificate - Project Management
Fleming College
04.2024
MSc - Biochemistry
Panjab University
India09.2021
Skills
- Data Analysis
- Logistics Coordination
- Project restructuring
- Deadline-oriented
- Idea Development and Brainstorming
- Microsoft Office
- Proposal Development
- Analytical Thinking
- Flexible and Adaptable
- Networking
- Excellent Communication
- Critical Thinking
- Supervision and leadership
- Interpersonal Communication
- Organization and Time Management
- Active Listening
Interests
Student Administrative Council (SAC) Member
Enactus member (Keys to me Project)
Certification
Certified Associate Project Manager (CAPM)
Timeline
Drug Safety Associate
Parexel International Limited
11.2021 - 06.2023
Graduate Certificate - Project Management
Fleming College
MSc - Biochemistry
Panjab University
Certified Associate Project Manager (CAPM)
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