Principal Pharmacovigilance Officer

Job Description

Principal Pharmacovigilance Officer (Regulatory Affairs)


£35,000 - £45,000

My client is an established and growing pharmaceutical company. Due to ongoing expansion they are now searching for a Principal Pharmacovigilance Officer to join their Regulatory Affairs team.

The main objectives and responsibilities of the role would be:

· Signatory for PSURs and product safety reviews in lieu of QPv
· Prepare PSUR’s 3-yearly to maintain licences for designated products.
· Report ADRs to regulatory authorities.
· Signatory for expedited reporting decisions.
· Keep an overview on all expedited reporting decisions. Has the final sign off on difficult decisions.
· Perform expedited reporting decisions in conjunction with senior staff.
· Receive and process ADRs received from the MHRA.
· Receive and process literature searches.
· Perform case triage and duplicate checks of ASPRs and literature, identifying and categorising suspected ADRs.
· Perform QC checks on peer data entry.
· Liaise with external pharmacovigilance providers, translation companies and the BL.
· To update the tracker and safety database with new information.
· To prepare and present PSRs annually to maintain licences for designated products.
· Lead product safety review meetings and PSUR meetings.
· Update and originate SOPs and WRKs.
· Deliver training presentations within the department.
· To be available to answer customer queries and support and train others on technical queries.
· Deliver training presentations in safety signal review meetings.
· Prepare abbreviated prescribing information for promotional literature.
· Perform induction training to new staff inside and outside the department on the basics of PVG and their responsibilities.
· Draft letters to customers regarding customer complaints that involved ADRs.
· Discuss and provide input on safety issues with QPv, suggesting actions to be employed.
· Assumes all responsibilities of the QPv in their absence.
· Contact for and co-ordinates inspections.

The successful candidate will come from a Medical/Biological degree ideally with a Pharmacology degree. Experience within a pharmaceutical regulatory affairs/ pharmacovigilance department is a necessity. Candidates must have a good understanding and practical experience of Volume 9a, and be conversant with new PVG legislation. Strong written and verbal communication skills with very strong attention to detail.

To be considered for this position, please forward your CV to Brendan Rogers @ PULSE Scientific.