COSMINA DARIA MARZA

+40786148539  Cluj-Napoca, Romania  darianaftan@yahoo.com

Senior Medical Safety Analyst

Positive attitude | Excellent organization skills | Adaptability and flexibility

Biologist by qualification working in Drug Safety and Pharmacovigilance for over 3 years. Technical
proficiencies in Safety Databases (Argus, SafetyEasy, ArisG, Veeva Vault). Strong knowledge of Good
Clinical Practice (GCP), Good Pharmacovigilance Practices (GVP) Medical Dictionary for Regulatory
Activities (MedDRA), Microsoft Office (MS Word, MS Excel, MS PowerPoint and MS Outlook). Also, a
great team player with leadership, communication and mentoring skills and detail oriented with
problem-solving, able to work in team or independently to meet the business needs.

WORK EXPERIENCE
AbbVie - Cluj-Napoca, Romania MAY 2022 -
Senior Medical Safety Analyst
• Triages incoming SAE information to fulfill timely reporting according to the authority/regulatory
requirements.
• Participate in safety surveillance activities for assigned products; and also, in area projects/goals.
Identify and escalate problems to manager.
• Collecting, analyzing, and triaging Adverse Events including reporting Serious Adverse Events to
IND safety including follow-up.
• Timely assessment of adverse event coding for consistency and accuracy of coding.
• Timely, accurate and effective medical review of safety-related CRFs and labs, including
communication with Study Designated Physicians.
• Interface with study manager, Clinical Research Organizations, Clinical Research Associates, Data
Management, and Pharmacovigilance to assure query resolution.
• Creation of narratives of serious adverse events and other identified adverse events of interest in
accordance with accepted standards and with minimal revision required upon review.
• Work closely with study-specific contacts such as; Clinical Safety Manager, clinical research
organization, clinical research associates, data management, and pharmacovigilance.
• Responsible for clinical safety capture and report, as workload responsibilities are study-related
and have a major impact on regulatory compliance and product safety profile.
• Follow scientific arguments and identify safety data needs and adhere to resolution of data
completeness regarding all aspects of clinical safety that impact product approval, safety signal
identification, and patient safety.

ProductLife Group - Cluj-Napoca, Romania FEB 2021 – APR 2022

Senior Drug Safety Associate
 Participated in continuous improvement by generating suggestions, engaging in problem-
solving activities to support teamwork.
 Worked closely with the Line Manager to maintain optimum levels of communication to
effectively and efficiently complete
 Train / Mentor over 6 onboarding team members in 2021
Cosmina Daria Marza darianaftan@yahoo.com
 Experienced in Clinical Trial and Post Marketing
 Perform initial evaluation of reported adverse events (serious and non-serious) from all
sources and perform data entry in the Safety Database.
 Ensure accurate and consistent coding of all events for serious and non-serious cases
entered in the Argus/SafetyEasy with the use of MedDRA (Medical Dictionary for
Regulatory Activities
 Generate queries for missing or unclear information and follow-up with sites for resolution.
 Generate regulatory reports and perform submission of safety reports to Competent
Authorities
 Perform QC of SAEs processed by other PV Associates for errors, missing information, and
legibility. Ensures cases are processed per conventions, and regulations.
 Medical evaluation of safety reports
 Literature search
 Review and updating of SOP/WPDs and applicable quality documents
 Act as a local Safety Officer (LSO) according to specific country requirements.
 Responsible for CAPA writing & late case analysis.

Terapia A SunPharma Company - Cluj-Napoca, Romania SEP 2018 – JAN 2020

Pharmacovigilance Assistant

 Receipt, acknowledgement, tracking, data entry and filing of Individual Case Safety Reports
(ICSRs) in compliance with applicable regulations, procedures and in accordance with
client specific SOPs.
 Providing administrative support to the project team on behalf of the client.

 Receiving and returning safety messages and acknowledgement of receipt.

 Tracking periodic reports submissions.
 Archiving documentation
 Preparing documents final layout.
 Performing other miscellaneous administrative tasks (e.g. daily and monthly evidence of
work maintenance of the employee register etc).

 EDUCATION

Iuliu-Hatieganu University of Medicine and Pharmacy - Cluj-Napoca, Romania

MSc – Pharmacovigilance - Safety Monitoring of medicinal products, 2021 – present
Babes-Bolyai University - Cluj-Napoca, Romania
BSc – Biology, 2015 - 2018

PROFESSIONAL SKILLS
 Strong knowledge of European legislation
 Detail-oriented, customer- and quality-focused
 Capability to make concise, accurate and relevant synopses of medical text and data, and the
ability to write unambiguous medical text
Cosmina Daria Marza darianaftan@yahoo.com
 Proven flexibility and adaptability when working in a team and independently, using good
judgment in making decisions
 Good knowledge of medical terminology
 Good communication ability both in English and Romanian language
 Computer proficiency, an ability to work with web-based applications
 Ability to work independently and with tight timelines

VOLUNTEER EXPERIENCE
Organizatia Studentilor pentru Natura – Cluj-Napoca, Romania 2015-2018
 Organizing science symposium every year – active member (Young Researchers in
BioSciences)
 Helping first year students to adjust

CERTIFICATIONS
 ICH – GOOD PHARMACOVIGILANCE PRACTICE (GVP), Feb 2021
 ICH – GOOD CLINICAL PRACTICE ONLINE (GCP), Feb 2021
• MSSO – MEDDRA MedDRA coding Basics Advanced MedDRA coding, Feb 2021