Pharmacovigilance Manager
- Employer
- Hyper Recruitment Solutions
- Location
- Buckinghamshire
- Salary
- Industry Competitive
- Closing date
- 4 Mar 2019
View more
- Sector
- Pharmaceutical, Regulatory Affairs
- Contract Type
- Permanent
- Hours
- Full Time
Job Details
This position would suit an experienced Pharmacovigliance professional who can work independently with the ability to lead projects as well as supervise and train junior staff members.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Pharmacovigilance Manager will be varied however the key duties and responsibilities are as follows:
1. Individual Case Safety Reports ( ICSRs ) - You will review and triage Adverse Events ( AEs ) and prepare reports to be submitted to the MHRA, ensuring compliance is maintained. You will ensure you keep up-to-date on product knowledge and perform local literature reviews.
2. Development / Periodic Safety Update Reports ( DSUR / PSUR ) - You will provide input for the UK region to assist with PSUR and DSUR reporting as and when required to ensure Global reports are updated. You will also liaise closely with Regulatory Affairs teams to ensure Reference Safety Information is current and correct.
3. 3rd Party Vendors - You will negotiate and agree Pharmacovigliance Vendor Service Agreements with external suppliers while ensuring current vendors are reviewed and maintained. You will be expected to manage your vendors and ensure that their reports are reviewed to maintain compliance. You will provide training where required.
4. You will ensure that the Regional Pharmacovigilance Lead is provided oversight of the local Pharmacovigilance activities. You will ensure that SOPs are maintained and updated and author procedures where required.
ROLE REQUIREMENTS:
To be successful in your application to this exciting opportunity as the Pharmacovigilance Manager we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences discipline (e.g. Biology, Chemistry, Pharmacology, Toxicology etc.) in addition to extensive Pharmacovigilance experience, ideally with experience of UK local authorities such as the MHRA.
2. Proven industry experience of Pharmacovigliance case reporting including Adverse Drug Reactions (ADRs), Adverse Events (AEs) and ICSRs in addition to experience of ensuring Pharmacovigilance compliance.
3. A working knowledge and practical experience with managing 3rd Party Vendors would be beneficial to your applications as well as experience of supporting local Responsible Person for Pharmacovigliance or QPPV.
Key Words: Pharmacovigilance | Drug Safety | ICSR | PSUR | DSUR | ADR | AE | PV | Pharmacovigilance Compliance | QPPV | RPPV | MHRA | UK
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.
Company
Hyper Recruitment Solutions is a specialist and highly compliant recruitment consultancy dedicated to the Science and Technology sectors.
Hyper Recruitment Solutions (HRS), founded and run by Ricky Martin and in partnership with Lord Alan Sugar, has a wealth of recruitment expertise as well as compliance and commercial awareness. We offer a range of permanent, temporary and contract staff.
Our vision is to provide recruitment solutions which will assist in the improvement and quality of life for all. To do so, HRS will focus on the support of sectors whose primary focus is in making the world a better place. This could be working for a Pharmaceutical company who is developing new and existing therapeutics or an FMCG business who is making the latest consumer products in a sustainable and efficient way. We want to provide a service to those areas of actual need which will have an impact on us all.
We provide services across a broad range of industries including the following specialist sectors:
• Biotechnology
• Pharmaceutical
• Medical Device
• Clinical Research
• CMO / CRO
• Food / FMCG
• Engineering
• Science
With all jobseekers we are looking to form close relationships where we can offer you the most accurate and useful advice. We intend to not only find and present the most ideal career options to you, but we want to provide advice on the entire recruitment process. We are a business who listens and advises and as shown on our website we have a clear ‘candidate commitment’ to ensure your search is in the most professional and capable hands. Some of the key areas we focus on include:
• Quality Assurance (including Qualified Persons)
• Clinical Research (all phases and therapeutic fields)
• Bioinformatics
• Research & Development
• Consumer Insight and Sensory
• Lean and Continuous Improvement
• Engineering (all disciplines)
• Manufacturing, Scale up and Technology Transfer
• Packaging and Sustainability
• Medical Affairs
• Sales and Business Development
• Information Systems & Technology
• Executive Appointments
HRS has been awarded membership to the REC (Recruitment and Employment Confederation) and APSCo (Association of Professional Staffing Companies). This is to assure all clients and candidates that our processes and practices comply with all relevant government and recruitment industry regulations.
Lord Sugar, Ricky Martin and everyone at HRS look forward to working with you. Please do not hesitate to visit our website www.hyperec.com or contact us via
Telephone: 02032 255 120
Email:info@hyperec.com
Or any of the social media routes below:
Twitter
Facebook
Linked in
Google +
- Website
- http://www.hyperec.com/
- Telephone
- 0203 910 2980
- Location
-
Amshold House
Goldings Hill
Loughton,
Essex
IG102RW
GB
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