Malene Nielsen Strøyberg Email & Phone Number

Ballerup Municipality, Capital Region Of Denmark, Denmark

• Provide pharmacoepidemiological expertise and experience to projects across LEO.• Propose, design and lead LEO funded observational disease or drug studies based on secondary data.• Drive and support LEO sponsored pharmacoepidemiological research through external collaboration and vendors• Train colleagues across LEO in observational study methodology, strengths and limitations.• Pharmacoepidemiological and epidemiological input to Clinical Development Plans (CDP) • Regulatory interaction: Pharmacoepidemiological support in regulatory interactions e.g. PASS and PAES commitments.• Department procedures: Contribute to the development of the procedures in Section of Pharmacoepidemiology (e.g. relevant parts of SOPs, development of templates) as required.

Ballerup

• Therapeutic area: dermatology• Migrating regulatory electronic and print data from Astra Zeneca and Astellas to LEO Pharmas EDMS system (eDoc) and Regulatory Information Management System (eRIMS) based on Indexing Instructions, SOPs and Work Instructions• Creating systems and processes to ensure smart and logical data collection and transformation• Subject Matter Expert (SME) for: conducting Data Integrating Tools, tool support, transfer of Health Authority Commitments and translation process of labeling documents• Reviewing module 3 documentation, CCDS, Labelling documents (SmPC/PIL/labelling)• Creating, updating, QCing, reviewing and approving of Registration Summaries• Documenting Regulatory Processes, using Visio.Involvement in Post-Authorization Safety Study (Medical Department)• Evaluating the pharmacoepidemiological analyses conducted in phase I, for planning phase II.

Technical University Of Denmark & Gentofte Hospital

• Therapeutic area: asthma.• Project management, handling and analyzing data as well as communicating complex methods and findings to other professionals.• With the realization that my competencies and passions are better expressed in a more relational and operative work environment, I decided to stop the fellowship

Copenhagen Area, Denmark

• Therapeutic area: cancer • Managed a large ongoing patient experience survey and conducted various coordinating and administrative tasks.• Co-authored and reviewed scientific papers, reports and presentations. • Conducted statistical and epidemiological analyses, and communicated findings to both professionals and non-professionals. • Supervised a master thesis student in statistic and epidemiology.

Copenhagen Area, Denmark

• Therapeutic Area: Reproduction • Worked under GCP • Collaborated closely with the teams of medical writing, trial management, biostatistics and regulatory affairs.• Anchorperson for some exploratory sub-studies from various phase II and III trials.• Conducted statistical and epidemiological analyses, and communicated clinical findings at international meetings and conferences.• Medical writing, poster development, scale validation and literature search.• Chairwoman for the Ferring Student Network, arranging works- hops and other events.

Copenhagen Area, Capital Region, Denmark

• Therapeutic area: Chronic Stress and Parkinson. • Authored scientific paper as first author, published in Epidemiology. • Epidemiological research conduction and communication of scientific findings. • Merged and modeled data from various register databases.

Plejecenteret Sjælsø

Work tasks included:• Helping with personal hygiene, • Wound care, • Changing colostomy bags • Cleaning urinary catheter tubes

Guatemala Area

•Taught basic statistics and organized a full-day workshop for all employees regarding social capital and how it can be measured (in Spanish). • Worked with implementation of violence prevention activities.

The National Institute For Disease Prevention, Copenhagen

• Entered and validated data from a WHO international longitudinal cohort study

Wales

• Voluntary work at a drug rehabilitation day center

Venezuela

Teaching English and mathematics at a local school, working as administrator, guide and bartender at a tourist camp

Hørsholm, Denmark

Teaching: • English • German • Mathematics • Swimming

Master'S Degree, Public Health, Master'S Thesis: A-

Activities and Societies: - Master’s thesis student at Ferring Pharmaceuticals A/S, DenmarkTitle of Master’s thesis: "Safety and efficacy.

Master'S Degree, Public Health

Activities and Societies: RowingExchange student

Bachelor'S Degree, Public Health, Bachelor'S Thesis: A+

Activities and Societies: - Bachelor’s thesis student at Oficinas de Derechos Humanos del Arzobispado de Guatemala (ODHAG).

College, Mathematical Student With Biology And Mathematics As High Level Electives