Sector: Life Sciences
Consultant: Josh Sidki
Salary: £30000 - £35000
Job Status: Permanent / Full Time
£30,000 – £35,000 Per Annum
My Clients Vision
The world of pharmacy is continually changing. In order to continue to thrive as a business, my client must understand the trends and forces that will shape their business in the future and move swiftly to prepare for what’s to come. In very much the same way, my client wants to help their customers prepare for tomorrow, today with the services we provide.
My Clients Mission
My clients mission statement is simple: “To continually grow a business where we have satisfied customers, satisfied suppliers and satisfied employees. Without these three ingredients, we have no company.”
My Client’s Profile
My client is an independent short-line wholesaler, offering an industry leading range that includes generics, branded medicines, OTC medicines, parallel imports, daily living aids, surgicals and unlicensed medicines.
Role of The PV Officer
- To ensure compliance with Good Pharmacovigilance Practice (GPvP)
- The PV Officer/QPPV is appointed as the management representative for the Quality Management System (QMS) for PV. He/she is responsible for ensuring the requirements of the QMS are implemented and maintained in an effective manner.
- Maintenance of the PV specific QMS and associated documentation (e.g. PSMF, SOPs etc) and records (e.g. deviations, change controls, audit reports).
- Act as system owner for the following PV specific QMS components:
– Internal Audits
– Complaints, Medical Information Enquires, Adverse Event Reporting
– Documentation / SOPs / Literature Reviews/ Product Safety Reviews
– Deviations and Non-Conformances
– Change Control
– Corrective and Preventative Actions (CAPAs)
– PSUR and RMP preparation and submission
– Technical Agreements and SDEA Collation
– Consulting with QPPV and medically qualified person on PV issues (when required)
– Review of ICSR process and reports
– Collating all adverse reports from various sources including ASPR’s, Literature Search and Spontaneous reports
– Electronic reporting to Health Authority
– Pharmacovigilance Training (Inclusive of Sigma Site Wide PV Training)
– Provision of PV Activities for other specified MAH’S
– XEVMPD new licences population in Eudravigilance
– Implementation of European Medicines Agencies(EMA) Pharmacovigilance Updates
– Deputising for specified duties in absence of QPPV (as specified in Pharmacovigilance SOP’S)
- Participation in competent authority inspections
- Ensure regular meetings are held with the Quality Assurance Team and implement decisions taken at the reviews.
– To comply with Health and Safety Regulations.
– To maintain the confidentiality of all information relating to the business activities of the Company (and sister companies)
– To attend relevant courses as demanded by the Company
– To perform other duties as directed by the Company
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