Sandra Predic
Miami,FL
Overview
6
6
years of professional experience
1
1
Certification
Work History
Research Associate 2
University of Miami Miller School of Medicine
10.2024 - Current
- Monitored progress against project timelines, ensuring timely completion of deliverables while maintaining high-quality standards.
- Set up equipment, organized inventory and maintained facilities.
- Provided technical guidance on experimental design and data interpretation issues for team members as needed.
- Gathered, arranged, and corrected research data to create representative graphs and charts highlighting results for presentations.
- Developed new protocols and improved existing laboratory processes.
- Participated in research projects by designing and executing experiments.
- Coordinated and managed laboratory projects and experiments.
- Troubleshot and resolved equipment and process issues.
- Participated in lab meetings and project presentations.
- Provided support and guidance to junior lab staff.
Safety & Pharmacovigilance Specialist
Syneos Health
04.2022 - 12.2023
- Managed the intake, tracking, and processing of Individual Case Safety Reports (ICSRs) in pharmacovigilance databases, ensuring accuracy and completeness in accordance with SOPs and safety management plans.
- Performed ICSR triage, verified data integrity, coded adverse events and medical history using MedDRA, composed narrative summaries, and resolved data discrepancies through query management.
- Ensured timely submission of expedited safety reports in compliance with global regulatory requirements; uploaded documentation to the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF) for both clinical trials and post-marketing programs.
- Maintained full compliance with SOPs, GCP, ICH guidelines, and regulatory frameworks across all stages of the drug development lifecycle.
- Coordinated closely with medical affairs teams to ensure accurate reporting of product-related adverse events from post-marketing studies and spontaneous reports.
Senior Pharmacovigilance Associate
PrimeVigilance
03.2020 - 04.2022
- Coordinated the monitoring and documentation of quality complaints and special situation cases, maintaining consistent daily communication with clients to ensure timely resolution.
- Collaborated with cross-functional project teams and delivered onboarding case processing training to new team members, contributing to smoother integration and operational efficiency.
- Managed daily workflow in coordination with workflow managers, proactively identifying bottlenecks and proposing effective solutions to improve turnaround times.
- Processed ICSRs from diverse sources (clinical trials, literature, spontaneous reports) in full compliance with global regulations, company SOPs, and client-specific protocols.
- Performed quality control of entered safety data, conducted ICSR follow-ups, managed SAE/SUSAR reconciliation activities, and ensured data privacy and regulatory compliance.
- Handled product quality complaints in coordination with Quality Assurance and Medical Information departments, facilitating prompt investigation and resolution.
Communications Assistant
Belgrade Open School
06.2019 - 02.2020
- Developed and implemented tailored social media strategies across multiple platforms to increase visibility and audience engagement.
- Monitored and analyzed campaign performance using Google Analytics and Facebook Insights, providing data-driven recommendations to optimize reach and effectiveness.
- Conducted research on emerging trends in audience behavior and media consumption to inform strategy development and content planning.
- Negotiated project budgets in collaboration with cross-functional teams, ensuring alignment with communication goals and resource constraints.
- Planned and executed events, overseeing logistics, client communication, and on-site coordination; managed live social media coverage and event photography to boost online engagement in real time.
Education
Master of Science - Molecular Biology And Physiology
University of Belgrade
Belgrade, Serbia10-2019
Bachelor of Science - Molecular Biology And Physiology
University of Belgrade
Belgrade, Serbia10-2017
Skills
- Molecular Biology: RNA isolation, DNA purification, cDNA synthesis and quality analysis
- PCR Techniques: RT-PCR, qRT-PCR
- Histology & Microscopy: Cryosectioning (OCT), H&E staining, Immunohistochemistry (IHC)
- Cell Culture: Primary cell culture techniques, sterile technique
- Microbiology Techniques: Bacterial culture, aseptic handling
- Biobanking: Clinical sample handling and storage for long-term research use
- Safety Database: Argus Safety (ICSR processing and case management)
- Productivity Tools: Microsoft Office Suite (Word, Excel, PowerPoint)
- Design & Imaging: Adobe Photoshop
Certification
- Project management - In house training, Belgrade Open School
- Python 101, Startit
- Certified Mediation Training Programme
Published Articles
- "Let's talk about negotiations" - 48th edition of the newsletter, 2019 at Belgrade Open School, Civilization at the Crossroads: Synthetic biology and European Union (26p)
- Collection of Essays at Belgrade Open School, 2019: Policy paper - European Union - In the search of the new Horizon(s) (192p); Case study: Crowdfunding as a tool for developing "Future studies" educational programme (207p)
Languages
English
Full Professional
French
Professional Working
Spanish
Limited Working
Timeline
Research Associate 2
University of Miami Miller School of Medicine
10.2024 - Current
Safety & Pharmacovigilance Specialist
Syneos Health
04.2022 - 12.2023
Senior Pharmacovigilance Associate
PrimeVigilance
03.2020 - 04.2022
Communications Assistant
Belgrade Open School
06.2019 - 02.2020
Master of Science - Molecular Biology And Physiology
University of Belgrade
Bachelor of Science - Molecular Biology And Physiology
University of Belgrade
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