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Pharmacovigilance Officer
Eingestellt von Apex International
Gesuchte Skills: Support, Marketing
Projektbeschreibung
Job Title: Pharmacovigilance Officer
Location: Middlesex
Duration: 12 month contract
The Client: Global Pharma Company
Benefits: Competitive Salary and benefits available - Full details available on application
The Role:
Updating the Pharmacovigilance database for processing of Adverse Events and Adverse Drug Reactions.
Conducting literature searches and obtaining literature articles and reviews.
Submission of AEs and ADRs in the appropriate format to the Regulatory bodies, in compliance with the statutory timelines.
Organising all cases into a comprehensive documentation system.
Compilation and presentation of submission metrics.
Highlighting any areas of concerns/discrepancies in the ADR arena. To ensure any ADR are reported to the regulatory authorities/affiliates.
Monitoring and maintaining an up to date knowledge of Pharmacovigilance regulations / guidelines.
Review of SmPCs against market leaders SmPC for generic clients.
Conducting reports for EudraVigilance and expedited cases as appropriate.
Conducting internal Pharmacovigilance training and mentoring support.
SOP writing and maintenance.
Maintaining the contract database with all the relevant documentation.
Updating and adding client's products to the XEVMPD (Extended EudraVigilance Medical Product Dictionary).
Preparation of periodic safety update reports (PSURs) - training will be provided.
Prepare organisation for regulatory authority PV Inspections by the MHRA, MPA, FDA including development and maintenance of SPS documents, follow up of corrective and preventative actions.
Working with International QA to plan & execute the internal PV audit programme, implement monthly compliance reports and assist GCP Inspection.
General Administration work related to Pharmacovigilance and managing all external and internal communication activities.
Full details available on application
The Candidate:
Must hold a medical qualification i.e. Medical Physician (excluding dental and veterinary).
Must have previous experience in reviewing literature cases and spontaneous cases i.e. ICSR.
Have an understanding of working with signal detection and risk management.
Have excellent communication skills (written and oral) to deal with both internal and external customers.
Have full knowledge and understanding of Pharmacovigilance guidelines - GVP modules: 1, 2, 6, 7, 11 and 16.
Ideally have previously worked within a Pharmacovigilance department.
Application Details:
If your skillset is relevant for this role, please click to apply on the link below. However, if this role doesn't suit your current skill-set, please call Alex on for further advice.
Candidates must provide confirmation that they have valid and existing permission to live and work in the UK.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment process.
About Apex: Apex International are an honest, knowledgeable and niche agency who recruit for the pharmaceutical, biotech and CRO sectors in the UK and EU. We specialise in the areas of: Medical Information, Medical Affairs, Pharmacovigilance, Drug Safety, Regulatory Affairs, Clinical Research, QA & QC, Clinical Data Management, Health Economics, Marketing and Pharmacy (Pharmacists, Pharmacy Technicians and Dispensers). For a confidential and professional chat about your job requirements with an agency who are expert in the fields they recruit for, and for the chance to register for free and receive weekly job updates, please call on or email
Apex International hold Investors in People status and are a corporate member of the Recruitment and Employment Confederation (REC).
Recommend a Friend Reward!!!! If you refer someone who is not currently registered with us and we find them a new position, Apex will repay you with a £200 voucher bonus (of your choice!)
Our Passion - Your Profession - A consultative approach to recruitment.
We match professional candidates to the best permanent, contract and interim roles in the market
Website:
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Location: Middlesex
Duration: 12 month contract
The Client: Global Pharma Company
Benefits: Competitive Salary and benefits available - Full details available on application
The Role:
Updating the Pharmacovigilance database for processing of Adverse Events and Adverse Drug Reactions.
Conducting literature searches and obtaining literature articles and reviews.
Submission of AEs and ADRs in the appropriate format to the Regulatory bodies, in compliance with the statutory timelines.
Organising all cases into a comprehensive documentation system.
Compilation and presentation of submission metrics.
Highlighting any areas of concerns/discrepancies in the ADR arena. To ensure any ADR are reported to the regulatory authorities/affiliates.
Monitoring and maintaining an up to date knowledge of Pharmacovigilance regulations / guidelines.
Review of SmPCs against market leaders SmPC for generic clients.
Conducting reports for EudraVigilance and expedited cases as appropriate.
Conducting internal Pharmacovigilance training and mentoring support.
SOP writing and maintenance.
Maintaining the contract database with all the relevant documentation.
Updating and adding client's products to the XEVMPD (Extended EudraVigilance Medical Product Dictionary).
Preparation of periodic safety update reports (PSURs) - training will be provided.
Prepare organisation for regulatory authority PV Inspections by the MHRA, MPA, FDA including development and maintenance of SPS documents, follow up of corrective and preventative actions.
Working with International QA to plan & execute the internal PV audit programme, implement monthly compliance reports and assist GCP Inspection.
General Administration work related to Pharmacovigilance and managing all external and internal communication activities.
Full details available on application
The Candidate:
Must hold a medical qualification i.e. Medical Physician (excluding dental and veterinary).
Must have previous experience in reviewing literature cases and spontaneous cases i.e. ICSR.
Have an understanding of working with signal detection and risk management.
Have excellent communication skills (written and oral) to deal with both internal and external customers.
Have full knowledge and understanding of Pharmacovigilance guidelines - GVP modules: 1, 2, 6, 7, 11 and 16.
Ideally have previously worked within a Pharmacovigilance department.
Application Details:
If your skillset is relevant for this role, please click to apply on the link below. However, if this role doesn't suit your current skill-set, please call Alex on for further advice.
Candidates must provide confirmation that they have valid and existing permission to live and work in the UK.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment process.
About Apex: Apex International are an honest, knowledgeable and niche agency who recruit for the pharmaceutical, biotech and CRO sectors in the UK and EU. We specialise in the areas of: Medical Information, Medical Affairs, Pharmacovigilance, Drug Safety, Regulatory Affairs, Clinical Research, QA & QC, Clinical Data Management, Health Economics, Marketing and Pharmacy (Pharmacists, Pharmacy Technicians and Dispensers). For a confidential and professional chat about your job requirements with an agency who are expert in the fields they recruit for, and for the chance to register for free and receive weekly job updates, please call on or email
Apex International hold Investors in People status and are a corporate member of the Recruitment and Employment Confederation (REC).
Recommend a Friend Reward!!!! If you refer someone who is not currently registered with us and we find them a new position, Apex will repay you with a £200 voucher bonus (of your choice!)
Our Passion - Your Profession - A consultative approach to recruitment.
We match professional candidates to the best permanent, contract and interim roles in the market
Website:
Keywords: Middlesex, Pharmacovigilance Officer, PV Officer, Drug Safety Officer, PV Associate, Pharmacovigilance Associate, Drug Safety Associate, Adverse Events, New Drug Development, Adverse Drug Reactions, AEs, ADRs, SmPCs, XEVMPD, SmPC, Middlesex, Pharmacovigilance Officer, PV Officer, Drug Safety Officer, PV Associate, Pharmacovigilance Associate, Drug Safety Associate, Adverse Events, New Drug Development, Adverse Drug Reactions, AEs, ADRs, SmPCs, XEVMPD, SmPC, Middlesex, Pharmacovigilance Officer, PV Officer, Drug Safety Officer, PV Associate, Pharmacovigilance Associate, Drug Safety Associate, Adverse Events, New Drug Development, Adverse Drug Reactions, AEs, ADRs, SmPCs, XEVMPD, SmPC,
Projektdetails
-
Einsatzort:
London, Vereinigtes Königreich
-
Projektbeginn:
asap
-
Projektdauer:
Keine Angabe
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
Marketing/Vertrieb, Sonstiges