Kirti Sharma
Bremen
Summary
Pharmacovigilance Specialist with extensive experience in safety event processing, signal detection, and post-marketing surveillance, ensuring compliance with global regulatory standards, including FDA, EMA, and GCP. Expertise in managing Individual Case Safety Reports (ICSRs), reconciling safety databases, and supporting audits and inspections, along with proficiency in safety data management systems such as ARISg and ARGUS. Recognized for exceptional attention to detail and strong communication skills, fostering effective collaboration within cross-functional teams. Currently based in Bremen, Germany, holding a valid EU work permit, and poised to leverage project management and data analysis skills to drive team success and achieve positive outcomes.
Overview
4
4
years of professional experience
1
1
Certification
Work History
INTERN – STUDY NURSE (Phase III Clinical Trials)
STUDIENZENTRUM BRINKUM
08.2025 - Current
- Assisting in the documentation and data management of ongoing Phase III clinical trials in accordance with GCP and regulatory standards.
- Supporting patient coordination, including scheduling visits, managing informed consent forms, and follow-up documentation.
- Recording and reporting adverse events as part of pharmacovigilance procedures.
- Collaborating with physicians, study coordinators, and clinical monitors to ensure protocol compliance and data integrity.
DRUG SAFETY ASSOCIATE-I
PAREXEL INTERNATIONAL SERVICES INDIA PRIVATE LIMITED
12.2021 - 07.2023
- Conducted triage and data entry of ICSRs, ensuring accurate qualification for expedited reporting.
- Assessed adverse events for expectedness against labeling documents and regulations.
- Performed literature reviews to identify safety signals for both pre- and post-marketing products.
- Led the reconciliation of safety databases with partners and competent authorities.
- Managed compliance monitoring, identifying root causes of deviations, and implementing corrective actions.
- Supported post-marketing activities, including preparation of Risk Management Plans (RMP) and Periodic Benefit-Risk Evaluation Reports (PBRER).
- Assisted in signal detection and risk management activities in collaboration with safety scientists.
- Actively contributed to audits and inspections by ensuring compliance with pharmacovigilance processes.
- Collaborated with cross-functional teams, including project managers, ICON medical monitors, and external stakeholders, to resolve safety issues.
- Conducted comprehensive literature reviews to stay informed on new drug safety findings and trends.
- Participated in ongoing training programs, honing skills necessary for success in the field of pharmacovigilance.
- Strong MS-Office skills (Excel, Word, Power Point, Outlook etc.)
- Key Achievements:
- Reduced case processing times by 15% through process improvements.
- Ensured 100% compliance with safety data exchange agreements.
Education
MASTER'S - PHARMACOVIGILANCE AND CLINICAL RESEARCH
Chitkara University
06.2021
BACHELOR'S - LIFE SCIENCE
Chaudhary Charan Singh University
06.2016
Skills
- Proficient in ARISg and ARGUS platforms
- ICSR data management expertise
- Compliance Monitoring: Strong knowledge of global regulatory frameworks (FDA, EMA, GCP)
- Safety Event Management: Pre- and post-marketing surveillance, medical devices, and drug safety
- Signal Detection: Supporting risk management and safety monitoring
- Post-Marketing Activities: PSMF, RMP, and PBRER creation
- Literature Review: Identifying and analyzing safety information from scientific sources
- Communication: Excellent written and verbal skills in English, basic German (A2 level)
- Collaborative Teamwork: Liaison with investigational sites, sponsors, and stakeholders
- Audits & Inspections: Support in pharmacovigilance audits and inspections
- Effective team participation and knowledge retention
- Analytical problem-solving and skilled in using Microsoft Office tools
- Quality management and detail-oriented data entry
- Strong verbal and written communication skills
Certification
- GCP Certified, Novartis - 23-Apr-2025
- Health Canada Division 5 Drugs For Clinical Trials Involving Human Subjects Training - 11-Aug-2025
- Electronic Safety Reporting in Vault CDMS (17JAN2024) - eCV2.0 Training - 11-Aug-2025
LANGUAGE SKILLS
Mother tongue(s): Hindi
Other language(s): English (Fluent), German (Intermediate)
Timeline
INTERN – STUDY NURSE (Phase III Clinical Trials)
STUDIENZENTRUM BRINKUM
08.2025 - Current
DRUG SAFETY ASSOCIATE-I
PAREXEL INTERNATIONAL SERVICES INDIA PRIVATE LIMITED
12.2021 - 07.2023
BACHELOR'S - LIFE SCIENCE
Chaudhary Charan Singh University
MASTER'S - PHARMACOVIGILANCE AND CLINICAL RESEARCH
Chitkara University
AVAILABILITY
Immediately available for roles across Europe. EU work permit holder.