Marianna F

Team Lead - Project Management

Safety • Full time

Apr 2023 - Present • 3 yrs 4 mos

•Support pharmacovigilance operations within global clinical research and drug safety environments in compliance with GVP standards. •Oversee PV operational workflows including case processing oversight, quality tracking, escalation management, and cross-functional coordination. •Monitor safety operations performance indicators, quality metrics, and compliance requirements across multiple PV workstreams. •Support governance-related reporting activities including operational dashboards, quality summaries, and compliance documentation for leadership and clients. •Coordinate communication between PV operations, quality teams, and client stakeholders to ensure regulatory alignment and issue resolution. •Contribute to process optimization initiatives aimed at improving PV compliance, efficiency, and data quality. •Support operational continuity across multiple pharmacovigilance projects and workstreams. •Supervise and coordinate teams of 10–65 professionals within regulated PV environments.

University Professor

Freelancing Career • Freelance

Jul 2020 - Present • 6 yrs 1 mo

•Delivered undergraduate-level lectures in pharmaceutical sciences courses taught include: Pharmaceutical and Cosmetics Technology, Radiopharmaceuticals and Polymers & Biomaterials. •Designed classes, examinations, assessments, and grading frameworks. •Developed structured educational materials aligned with pharmaceutical and clinical science frameworks. •Supported curriculum development and academic program enhancement. •Mentored students in clinical reasoning and evidence-based practice. •Supervised student research projects and thesis development in pharmaceutical disciplines.

Safety Specialist - Case Processing

Safety • Full time

May 2021 - Mar 2023 • 1 yr 10 mos

•Performed end-to-end pharmacovigilance case processing including intake, triage, coding, narrative development, review, and case completion activities. •Conducted MedDRA coding and ensured consistency in terminology application across safety databases. •Managed follow-up activities to ensure completeness and accuracy of safety data for regulatory reporting requirements. •Performed case narrative preparation and review ensuring compliance with internal procedures and GVP standards. •Conducted case reconciliation activities across pharmacovigilance systems and databases. •Utilized Argus Safety and additional PV systems for structured safety data processing and case management. •Generated case reports, exports, and operational summaries supporting compliance monitoring and leadership reporting. •Maintained high-quality pharmacovigilance outputs with consistent quality performance above 99%. •Demonstrated strong operational efficiency with productivity levels up to 125% of defined targets. •Supported safety data operations across pharmaceutical and cosmetic vigilance programs with variable case volumes. •Provided support in team coordination, mentoring, and operational guidance for assigned PV activities.