Travelling
Sudha Sharma
Pharmacovigilance Associate
Gurgaon
Summary
Logical Pharmacovigilance Associate with background identifying, assessing and preventing adverse effects or medications and related pharmaceutical items. Dedicated expert with focus on maintaining drug safety by preparing and reviewing data and reports. Meticulous when authoring professional documents and reviewing scientific literature.
Overview
9
9
years of professional experience
5
5
years of post-secondary education
Work History
Pharmacovigilance Associate
Wipro GE Healthcare Pvt Ltd
GURGAON
11.2019 - Current
- Oversaw adverse events case reporting and conducted follow-up.
- Supported inspections, visits and audits as well as CAPAs management.
- Reviewed, compiled and analyzed data for safety database management.
- Conducted case reconciliation with internal departments, distributors, affiliates and business partners.
- Developed new or improved pharmacovigilance procedures.
- Authored and managed regular safety update reports.
- Assisted with preparation and implementation of pharmacovigilance agreements and contracts.
- Responded to requests from regulatory agencies and notified to share information.
- Trained staff and updated training documents to meet regulations and standards.
- Assessed and distributed pharmaceutical product adverse event documents.
- Monitored deliverables for quality and adherence to regulatory reporting timelines.
- Conducted data review and followed standard practices to find solutions.
- Reported problems and concerns to management.
Coordinator Hepatology
Medanta The Medicity
GURGAON
06.2016 - 11.2019
- Strengthened communication skills through regular interactions with others.
- Proved successful working within tight deadlines and a fast-paced environment.
- Developed and maintained courteous and effective working relationships.
- Self-motivated, with a strong sense of personal responsibility.
Clinical Counselor
Cipla
GURGAON
06.2014 - 06.2016
- Linked clients to other programs and community agencies to enhance treatment processes.
- Provided psychotherapy incorporating cognitive-behavioral, client-centered and play-therapy to treat wide range of psychological problems in patients.
- Mitigated injuries and de-escalated life-threatening events through effective crisis intervention and coordination of emergency services.
Education
B Pharmacy - Pharmaceutical Sciences
GJU of Science & Technology Hisar
Hisar 05.2011 - 07.2014
Skills
Data interpretation,
Training and Development
Flexible and Adaptable
Corrective actions
Argus
Veeva RIM Vault
Accomplishments
Rewarded for setting good relationships with Government authorities.
Successfully faced two global audit with no major findings.
Nominated by NCC PVPI as a speaker.
Interests
Timeline
Pharmacovigilance Associate
Wipro GE Healthcare Pvt Ltd
11.2019 - Current
Coordinator Hepatology
Medanta The Medicity
06.2016 - 11.2019
Clinical Counselor
Cipla
06.2014 - 06.2016
B Pharmacy - Pharmaceutical Sciences
GJU of Science & Technology Hisar
05.2011 - 07.2014