Pharmacovigilance Specialist - Local Safety Officer

I am currently partnered with a market leading business, specialised in providing Pharmacovigilance support to selected partners. Due to the continued success and global development of the business, they are actively looking to bring an exceptional Pharmacovigilance specialist into the business. If you have strong Pharmacovigilance experience and are looking for a role within a flourishing business, please read on….

Role

• To act as Local Safety Officer within assigned territory and be contact person for pharmacovigilance at local level Including notification to relevant Competent Authorities, if applicable
• To  monitor local regulations and immediately notify relevant  persons in case of significant changes
• Ensure compliance with regulation and maintenance of local pharmacovigilance system
• To Maintain communication with local Competent Authorities and Clients
• To meet compliance requirements, track performance and regularly provide requested reports on  Key Performance Indicators
• Monitor inbox and ensure all actions are conducted accordingly
• Ensure collection, processing, duplicate check, accurate translation, quality control undertaken
• Reporting and follow-up of all safety reports within agreed timelines
• To ensure immediate collection, processing and notification to all concerned parties of any product quality complaint or medical enquiry/answer received via phone/e-mail/fax or by other means from any source

• To assist  with additional risk minimisation implementation and tracking
• To assist in RMP, DSUR, PSUR translation and submission, if required.
• To perform signal detection at local level and reporting to Competent Authorities

Requirements

• Minimum of 2 years of Pharmacovigilance experience(experience as local safety officer is an advantage)
• Broad range of exposure to full Pharmacovigilance process
• Strong Swedish and English language skills
• Ability to self-manage as required

If you are interested, get in touch with me ASAP…

Dan Hockaday

Pharmacovigilance & Drug Safety Recruitment Consultant

Email: Dhockaday (at) barringtonjames.com

Phone: 00441293776644