Experience

PharmaRelations

• Sweden
• Business Consulting and Services
• 100 - 200 Employee

• Head of Pharmacovigilance, Senior Pharmacovigilance Specialist

  • Aug 2020 - Present

  PharmaRelations is a Nordic Consulting and recruitment company specializing in the Life Science sector. We provide professionals with a high level of expertise through our Contract Staffing, Recruitment and Outsourcing services. We create added value for our clients and professional development and careers for our associates. PharmaRelations’ client base is pharmaceutical-, medical technology- & biotechnology, OTC- and well-being-, dental care and animal health care sectors. In my role as Head of Pharmacovigilance, I am responsible for our PV services in-house. Our team includes Senior PV Specialists that previously held various senior positions such as PV Inspector, Auditor and QPPV. I am interested to hear more about your business, your needs, if we can help you in any way and tell you more about us and what services we offer. Do not hesitate to contact me at +46 70 165 22 54. Show less



Medical Products Agency Läkemedelsverket

• Sweden
• Government Administration
• 500 - 600 Employee

• Pharmaceutical Inspector Pharmacovigilance

  • Oct 2018 - Aug 2020



Sobi - Swedish Orphan Biovitrum AB (publ)

• Sweden
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Global QA Auditor GVP, GCP & HCC

  • Aug 2015 - Sep 2018

  • Assist in the preparation of the GCP, GVP and HCC QA audit plans • Perform GCP, GVP and HCC audits of HQ performed activities and of those affiliates and vendors where Sobi AB (Publ) outsources any such activities. • Ensure that appropriate independent audits are delivered according to the audit plan • Provide the QMS Operational Committee with quality updates including summarized results from GCP, GVP and HCC audits • Review resolution/CAPA plans for critical/major audit findings • Summarize audit plans and audit results to the QMS Operational Committee • Provide independent quality assessment concerning compliance with appropriate regulations and SOPs. • Prepare, coordinate and follow-up GCP, GVP and HCC audits (when Sobi is auditee). • Assist in the preparation for, facilitate and follow-up GCP, GVP and HCC inspections by regulatory authorities. • Write QA operational SOPs for GCP, GVP and HCC. • Provide advice in quality related issues for GCP, GVP and HCC. Show less



Baxalta

• Pharmacovigilance Compliance Monitor, Europe, Middle East & Africa

  • May 2015 - Jul 2015

  The roll Pharmacovigilance Compliance Monitor Europe, Middle East and Africa is a part of the Global Pharmacovigilance Compliance function, reporting to Pharmacovigilance Compliance Manager, headquarters, USA. The work include close collaboration with the European Qualified Person Responsible for Pharmacovigilance (EU QPPV), EU QPPV Deputy, Senior Pharmacovigilance Compliance Monitor EMEA, Regional Pharmacovigilance team, Data Management, Pharmacovigilance Technology and Global Information Technology. The work include contribution to the development of monitoring and oversight of the Pharmacovigilance System, production of consistent and reliable metrics reports for monitoring and oversight of compliance and monitoring and oversight of all activities related to the Pharmacovigilance System within the EU. The work also include supporting Pharmacovigilance inspections conducted by Regulatory Authorities by fulfilling inspection requests and responding to and tracking inspection findings and participate in internal Pharmacovigilance audits as subject matter expert. Show less



Baxter International Inc.

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Pharmacovigilance Compliance Monitor Europe, Middle East & Africa

  • Jan 2013 - Apr 2015

  The roll Pharmacovigilance Compliance Monitor Europe, Middle East and Africa is a part of the Global Pharmacovigilance Compliance function, reporting to Pharmacovigilance Compliance Manager, headquarters, USA. The work include close collaboration with the European Qualified Person Responsible for Pharmacovigilance (EU QPPV), EU QPPV Deputy, Senior Pharmacovigilance Compliance Monitor EMEA, Regional Pharmacovigilance team, Data Management, Pharmacovigilance Technology and Global Information Technology. The work include contribution to the development of monitoring and oversight of the Pharmacovigilance System, production of consistent and reliable metrics reports for monitoring and oversight of compliance and monitoring and oversight of all activities related to the Pharmacovigilance System within the EU. The work also include supporting Pharmacovigilance inspections conducted by Regulatory Authorities by fulfilling inspection requests and responding to and tracking inspection findings and participate in internal Pharmacovigilance audits as subject matter expert. Show less



Home

• Maternity leave

  • Apr 2012 - Jan 2013



Hays

• United Kingdom
• Staffing and Recruiting
• 700 & Above Employee

• Head of Country Pharmacovigilance Sweden

  • Mar 2011 - Apr 2012

  Contract placement at Bristol-Myers Squibb. Contract placement at Bristol-Myers Squibb.



Bristol Myers Squibb

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Contract placement Head of Country Pharmacovigilance Sweden

  • Mar 2011 - Apr 2012

  The work as Head of Country Pharmacovigilance Sweden included overall responsibility for all pharmacovigilanse activities in Sweden and back-up for the Nordic Pharmacovigilance colleagues; supervised PV Associate, responsible for training of non PV staff in Denmark, Norway and Sweden, point of contact for the local HA, ECs, partners and colleagues for PV related issues, establish and update Safety Data Exchange Agreements (SDEAs), Summary of Pharmacovigilance System (SPS) revision and update, PV audit preparation and conduct with favourable result, set up new processes and developed new tools to increase PV awareness and improve compliance and quality, collection, follow-up and processing of Individual Case Safety Reports (ICSRs) from various sources, database entry and handling, reconciliation, triage evaluation, reporting of ICSRs and Aggregrate Safety data to the Nordic Health Authorities (HAs) and Ethics Committees (ECs) etc. Show less



IRW Consulting AB – is now LINK Medical, A Nordic Full-Service CRO

• Sweden
• Pharmaceuticals
• 1 - 100 Employee

• Pharmacovigilance Associate/ Clinical Research Associate

  • Dec 2009 - Mar 2011

  Contract placements at different pharmacutical companies and also in-house at IRW Consulting AB.The work in-house at IRW Consulting AB as Pharmacovigilance Associate included collection, follow-up and processing of Individual Case Safety Reports (ICSRs) from various sources, quality control processes, triage evaluation, database entry and handling, MedDRA coding, E2B reporting, reporting to Regulatory Authority and Ethics Committee(s), PSUR writing, writing and updating of SOPs, development of educational material.The work in-house at IRW Consulting AB as Clinical Research Associate included project management, contract negotiations, preparation of contracts and study documents and archiving. Show less

• Clinical Research Associate

  • Aug 2006 - Dec 2009

  Contract placement at Bristol-Myers Squibb and also in-house at IRW Consulting AB. The work in-house at IRW Consulting AB included project management, preparation, coordination and approval of study documents, archiving and monitoring.



Merck

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Contract placement Pharmacovigilance Specialist

  • Oct 2010 - Feb 2011

  The work as Pharmacovigilance Specialist included collection, follow-up and processing of Individual Case Safety Reports (ICSRs) from various sources, reconciliation and quality control processes, triage evaluation, updating of SOPs, development of educational material and conducting training of non PV staff. The work as Pharmacovigilance Specialist included collection, follow-up and processing of Individual Case Safety Reports (ICSRs) from various sources, reconciliation and quality control processes, triage evaluation, updating of SOPs, development of educational material and conducting training of non PV staff.



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Contract placement Pharmacovigilance Officer

  • Dec 2009 - Sep 2010

  The work as Pharmacovigilance Officer included collection, follow-up and processing of Individual Case Safety Reports (ICSRs) from various sources, reconciliation and quality control processes, triage evaluation, database entry and handeling, E2B reporting, reporting to Regulatory Authority and Ethics Committee(s), writing and updating of SOPs, development of educational material and conducting training of non PV staff. The position also included role as Medical Information Officer. The work included providing evaluated answers to drug-related and medical questions from customers and co-workers. Show less



Bristol Myers Squibb

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Contract placement Nordic Associate Clinical Site Manager

  • Dec 2006 - Jun 2008

  The work included project management, budget preparation, handling and contract negotiations, writing protocol amendment, preparation, coordination and approval of study documents, archiving, planning and participating in investigator meetings, initiation visits, data review and data cleaning activities.

• Contract placement Nordic Clinical Trial Associate

  • Aug 2006 - Nov 2006

  The work included preparation, coordination and approval of study documents, archiving, planning and participating in investigator meetings.



Proffice

• Sweden
• Staffing and Recruiting
• 200 - 300 Employee

• Nordic Safety Assistant/ Clinical Trial Assistant/ Regulatory Assistant

  • Jun 2005 - Jul 2006

  Contract placement Nordic Safety Assistant/ Nordic Clinical Trial Assistant/ Nordic Regulatory Assistant at Janssen-Cilag AB. Contract placement Nordic Safety Assistant/ Nordic Clinical Trial Assistant/ Nordic Regulatory Assistant at Janssen-Cilag AB.



The Janssen Pharmaceutical Companies of Johnson & Johnson

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Contract placement Nordic Safety Assistant/ Clinical Trial Assistant/ Regulatory Assistant

  • Jun 2005 - Jul 2006

  The work as Nordic Safety Assistant included database handling of adverse drug reactions and reporting of adverse drug reactions to the Nordic Regulatory Authorities. The work as Nordic Clinical Trial Assistant included preparation of study documents and agreements, archiving, planning and participating in investigator meetings and initiation visits. The work as Nordic Regulatory Assistant included database entry of regulatory information. The work as Nordic Safety Assistant included database handling of adverse drug reactions and reporting of adverse drug reactions to the Nordic Regulatory Authorities. The work as Nordic Clinical Trial Assistant included preparation of study documents and agreements, archiving, planning and participating in investigator meetings and initiation visits. The work as Nordic Regulatory Assistant included database entry of regulatory information.