Karin Söderlind Email & Phone Number

Stockholm, Stockholm County, Sweden

Cross-functional role where I lead/managed various projects on behalf of the PV department, contributed to several improvements and was responsible for all internal/external communication: - Vendor Management & Relationship Building: Set up, onboarding and implementation for 25+ countries (Europa, Middle East, North Africa) incl. governance structure, stakeholder communication and relationship building with the vendor.- IT & digital: Migration and set up of new Microsoft 365 SharePoint sites incl. change management. Introduced various Microsoft 365 tools to the department to improve ways of working. Created a GxP process for SharePoint to mitigate potential risks.- Safety Training - developed a new e-learning, incl. annual maintenance and content updates- Staff Onboarding – Updates and improvements of the introduction program, created various presentations and templates. - Process improvements for e.g. benefit-risk process incl. roll-out and training - Communication & Engagement (internal and external): news posts, interviews, campaigns, podcasts, surveys etc- Workshops - led several workshops and tabletop exercises- Strategy & Content - provided insights to the leadership team

Stockholm, Sverige

Safety´s representative in the Termination team (together with Commercial, Regulatory, Supply Chain and Legal). My role was to ensure that all Termination Agreements fulfilled Pharmacovigilance (PV) requirements for safety reporting. I was also reviewing SDEA´s and other PV related agreements, incl. setup of a new SharePoint for PV Agreement oversight.

Stockholm, Sverige

Supported medical trainings and the marketing team with different tasks, for both pharmaceuticals and medical device. My daily work involved: Development and improvements of internal processes, create material and invitations to HCP´s for product training. Monitor and act against trademark infringements of company brands. Marketing analysis in various social media tools incl. presenting reports to customers. Collaborated with agencies and Compliance to launch a product webpage. Responsible for the “web shop”, where HCP´s could order clinic material, stock monitoring and design improvements.

Stockholm, Sweden

I was responsible for startup of the “Pharma department”- a new consultant competence at ALTEN. The role included:- Business development and strategy, including development of marketing material for the pharma industry- Sales & account management - Recruitment & leadership

Stockholm, Sweden

As supply team lead, I ensured delivery according to plan with regards to quality, GDP, budget, and timelines. I provided input to study protocol and wrote the pharmacy manual with instructions of drug preparation. In parallel, I continued to act in the role of Clinical Operations Manager as described below.

Stockholm, Sweden

The role involved several different responsibilities: - Project Manager within Regulatory/CMC/Clinical: collaborated with the team to achieve effective conduct of our clinical trials according to GCP, protocol, timelines, and regulations- Quality Assurance (QA) Coordinator: update of SOPs, staff training records, audit/inspection planning and archiving- Regulatory: submission of amendments, meeting requests, briefing documents, orphan drug application. Participated in scientific advice meetings with RA- Internal/external communication: including the company web page and the LinkedIn account

Stockholm, Sweden

- Preparation of various RA documents for submissions to authorities (EU and US) - Set-up of internal filing structure according to CTD and handled TMF filing- Founded the company biobank and reference library. Provided support to the leadership team.

Stockholm, Sweden

Extra job weekends and evenings. Represented the company as host for conferences, dinner parties and concerts by always providing the best possible service to the clients and guests.

Gavle, Sweden

Summer job 2009 and 2010: Immunological analysis of plasma samples (ISO certified environment).

Gavle, Sweden

Summer job 2007 and 2008: Quality assurance of the manufacturing process.

Master'S Degree, Biomedicin, Clinical Drug Development

Activities and Societies: Biomedicinska Föreningen (BMF)

Master Thesis, Cell/Cellular And Molecular Biology

”Nucleoside analogues potential as new antibiotics”. Developed a quick and easy screening assay for growth inhibition of nucleoside.