Ani Petrosyan
Richboro
Summary
High-performing professional with integrity and leadership skills. Applies knowledge and abilities to positively impact organization. Flexible in different situations and dynamic conditions. Works great under extreme stress and deadlines.
Overview
14
14
years of professional experience
Work History
Medical Safety Officer Support Physician/Safety Analysis Scientist
ClinChoice Inc. contracted by JnJ
09.2025 - Current
- Provide medical and scientific expertise as the GMS representative on the Compound Development Team (CDT) and Clinical Teams
- Active partner and core contributor of safety input to key regulatory or clinical documents including:
- Risk management plans
- Clinical Trial, EAP and IIS Protocols
- Informed Consent Forms (ICF), including Risk Language
- Safety Sections of Investigator’s Brochure (IB) and IB addenda
- Safety sections of Clinical Study Reports (CSR)
- Integrated Safety Summary (ISS) and Summary of Clinical Safety (SCS) for NDA/BLA/MAA filings
- Periodic Benefit Risk Evaluation Report (PBRER) Safety Update Report (PSUR), Development Safety Update Report (DSUR)
- Health authority queries
- Company Core Data Sheets (CCDS), US and EU prescribing information
- Signal Evaluations
Safety Analysis Scientist
ClinChoice Inc. contracted by JnJ
09.2022 - 09.2025
- Ensure timely, quality reports/safety analyses related to core deliverables with oversight as appropriate
- Collaborate with Therapeutic Area Safety Head (TASH)/MSO/Safety Surveillance Physician (SSP) and other stakeholders on strategy development
- Initiate/Conduct/Oversee searches of internal and external databases
- Perform and/or lead aggregate safety analysis and case level review
- Author, contribute, and coordinate the preparation of core safety deliverables (DSUR, IB, PBRER, PSUR, REMS, CO, CSR, Health authority queries)
- Provide Safety Management Team (SMT) support as needed
- Review, analyze, synthesize Individual Case Safety Report and narrative line listing data
- Act as ad hoc member for assigned products as appropriate
Pharmacovigilance Scientist
ClinChoice
Yerevan
10.2017 - 08.2021
- Product Literature Reviews
- Aggregate Data Reviews
- AE/PC review
- Joint review
Junior Researcher (Part time)
Tuberculosis Research and Prevention Center
Yerevan
01.2015 - 01.2021
- Carry out research activities
- Support grant application activities
- Design and execute studies
- Support database creation activities
- Plan and support data collection activities
- Conduct statistical analyses
Medical Writer
ClinChoice
Yerevan
11.2015 - 10.2017
- Create documents that describe research results, product use, and other medical information, and ensure compliance with Good Clinical Practice and relevant Standard Operating Procedures (SOPs), as well as regulatory guidelines in terms of content, format and structure
- Draft, revise and finalize the Study Protocol
- Prepare the Investigator’s Brochure
- Schedule a document review produced by Medical Affairs department and Quality Control timeline
- Assist to MW Lead in preparing the Clinical Study Report (CSR)
- Prepare CSR Appendices
- Prepare draft narratives according to patient data listings/statistical output and send draft narratives for peer-review
Gynecologist/Attending Doctor
Slavmed Medical Center
Yerevan
03.2014 - 01.2016
- Perform regular annual exams on patients
- Care for and treat women during prenatal, natal, and postnatal periods.
- Perform general gynecological and obstetric surgical procedures, both diagnostic and therapeutic
- Analyze records, reports, test results, or examination information to diagnose medical conditions
- Monitor patients over the course of treatment or pregnancies.
Resident Doctor / Residency
Republican Institute of Reproductive Health, Perinatology, Obstetrics And Gynaecology
Yerevan
09.2011 - 07.2015
- Perform regular annual exams on patients
- Care for and treat women during prenatal, natal, and postnatal periods.
- Perform general gynecological and obstetric surgical procedures, both diagnostic and therapeutic
- Analyze records, reports, test results, or examination information to diagnose medical conditions
- Monitor patients over the course of treatment or pregnancies.
Education
Residency -
Republican Institute of Reproductive Health, Perinatology, Obstetrics And Gynaecology
Yerevan, Armenia07.2015
Obstetrics and Gynecology
Yerevan State Medical University
Yerevan, Armenia06.2015
M.D. - General Medicine
Yerevan State Medical University
Yerevan, Armenia06.2011
Skills
- Windows
- MS-Office (Word, Excel, Power Point)
- Internet
- Outlook
Training
- QMS, ISMS and PIMS Trainings, ClinChoice LLC, 2021-2022
- Good clinical practice training, FMD K&L Europe, Yerevan, Armenia, 2016
Languages
- English, Fluent
- Russian, Fluent
- Armenian, Fluent
Professional Licenses Certifications
PMP certification, Project Management Institute, 2025
Timeline
Medical Safety Officer Support Physician/Safety Analysis Scientist
ClinChoice Inc. contracted by JnJ
09.2025 - Current
Safety Analysis Scientist
ClinChoice Inc. contracted by JnJ
09.2022 - 09.2025
Pharmacovigilance Scientist
ClinChoice
10.2017 - 08.2021
Medical Writer
ClinChoice
11.2015 - 10.2017
Junior Researcher (Part time)
Tuberculosis Research and Prevention Center
01.2015 - 01.2021
Gynecologist/Attending Doctor
Slavmed Medical Center
03.2014 - 01.2016
Resident Doctor / Residency
Republican Institute of Reproductive Health, Perinatology, Obstetrics And Gynaecology
09.2011 - 07.2015
Residency -
Republican Institute of Reproductive Health, Perinatology, Obstetrics And Gynaecology
Obstetrics and Gynecology
Yerevan State Medical University
M.D. - General Medicine
Yerevan State Medical University