Anna Pomerenke Email & Phone Number

Experienced translational medicine scientist- Ten years of hands-on experience in translational medicine teams, including extensive experience in leading research project, experimental design and execution, problem-solving, critical thinking, literature and document review- Knowledgeable about evaluation of novel drugs and familiar with ICH and FDA guidelines- Knowledgeable about disease processes and therapeutic areas in hepatology, respiratory, and infectious diseases- Self-motivated, attentive, systematic, flexible, able to prioritize and complete tasks with minimal supervision, able to quickly learn, implement and optimize new processes, comfortable with a remote-based work environment and virtual team setting

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  Post Market Surveillance Coordinator

  Lina Medical

  Nov 2022 - Present

  - Maintaining and improving the post market surveillance process- Collecting and analyzing data from diverse sources including customer feedback, complaints, and adverse event reports to identify trends and potential safety issues- Reviewing scientific literature and safety databases- Preparing and reviewing regulatory reports, i.e., PMS Reports, PSURs, PMCF Evaluation Reports- Coordinating cross-functional teams to address any product concerns - Contributing to risk management processes and benefit-risk assessments for marketed products- Staying current with evolving regulations and industry best practices in post market surveillance