Pharmacovigilance expert with experience in management of post-marketing and clinical trials PV. Hands-on experience in individual safety case processing, PV-databases, PSUR non-medical writing, PSMF maintenance, Pharmacovigilance agreements, PV-training, PV-audits (junior level) and PV-Quality. Practical understanding of team work and on the other side also experience in remote work and being individually responsible of defined tasks. Other: Experience in limited drug regulatory tasks, agreement administration and trademark management.
Senior Pharmacovigilance Specialist
Since June 2014
Pharmacovigilance. General Office work. Assisting in drug regulatory tasks. Agreement administrator. Trademark assignment coordinator.
March 2014 --- May 2014
Senior Drug Safety Specialist
October 2013 --- March 2014
Senior Drug Safety Specialist role including individual safety case report processing, managing periodic report submissions to health authority and ethic committees, managing local safety instructions and local SOP updates and administration. Senior level qualifications in clinical trials drug safety. Experience in GVP, GCP and specific tools like ARISg. Internal PV-quality responsibilities including experience in partner auditing. Pharmacovigilance training and support for internal and external stakeholders. Deputy Local Safety Responsible.
Senior Drug Safety Quality Specialist
August 2007 --- October 2013
Senior Specialist in Drug Safety with experience in various drug safety tasks starting from case management both in spontaneous and clinical adverse event reporting to pharmacovigilance system maintenance including process quality & risk assessment tasks as well as compliance related work. Experience in team and project coordination. Experience in process development and in drug safety training. Team leading tasks. Experience in working in international environment in project work in Roche UK European Drug Safety Unit. Role of Local Safety Responsible/ deputy Local Safety Responsible.
Drug Safety Officer
January 2005 --- August 2007
Drug Safety related work including main responsibility of clinical SAE reporting. Various drug safety tasks including AE case processing, SOP writing, drug safety trainer, local process development, team coordinating including Local Safety Responsible (LSR) role 2010 - 2012.
Drug Safety Specialist
January 2002 --- January 2005
Drug Safety Specialist in Periodic Reporting at Orion Central Drug Safety Department. Responsible for Periodic Safety Update Report preparations and distribution including writing of non-scientific sections of PSURS, line listing preparation and management of distribution of the final report. Responsible of Standard Operating Procedure (SOP) writing and management in electronic SOP-system. Ownership of defined SOPs including training responsibility of those.
Drug Safety Specialist
January 2000 --- January 2002
Individual Safety Case Report processing, authority submissions, training for other company units in drug safety reporting.
Clinical Supply Coordinator, Regulatory Associate
January 1998 --- January 2000
Clinical Supplies logistics and storage responsibilities. Regulatory tasks like variation application and packaging material reviews. Assisting in product complaint management process- Clinical SAE-reporting to health authority.
Bachelor's degree in Pharmacy from Helsingin yliopisto in 0
Master of Science (M.Sc.) in from Tampere University in 0