Information:
Job Vacancy Details
Principle Pharmacovigilance Officer
Leading Pharmaceutical Organisation
West Yorkshire
Permanent ⁄ £40000 - £45000
Updated March 6, 2012
Michael Page Life Sciences are working with a leading pharmaceutical organisation to find a Principal Pharmacovigilance Officer. This is a family cultured company that specialises in the development, manufacture and marketing of oral liquid medicines in a vast and varied product range including corticosteroids, analgesics, diuretics, antibiotics and anti-psychotics.
As Principal Pharmacovigilance Officer you will report to the QPPV and Regulatory Affairs Manager and you will have the following responsibilities:
Key Responsibilities:
• 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.
• 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.
• Update the tracker and safety database with new information.
• 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.
• 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.
• 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.
Who we're looking for
• The role will require you to possess a relevant scientific degree, preferably in Pharmacology. You will have experience in the following areas:
• Pharmacovigilance legislation as well as a good understanding and practical experience of volume 9a is crucial.
• You must be competent to cover technical and medical information queries when required.
• You should be a organised, proactive, results driven, positive, confident and motivated individual with exceptional attention to detail, communication skills, project management skills and problem solving skills.
About our client
Leading Pharmaceutical Organisation
What's on offer
This is an exciting opportunity within a career driven company offering excellent benefits including competitive salaries, a pension scheme, private healthcare, free parking, a company reward scheme, attendance bonuses, and a generous holiday entitlement.
Michael Page Contact
For further info, apply or phone on 0113 388 9000.
Job Ref: 13212551
Your application will be sent to Emma Whittle.
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