Senior Pharmacovigilance Officer
- Employer
- Hyper Recruitment Solutions
- Location
- Berkshire
- Salary
- Competitive
- Closing date
- 15 Mar 2019
View more
- Sector
- Pharmaceutical, Quality Assurance, Regulatory Affairs
- Contract Type
- Permanent
- Hours
- Full Time
Job Details
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Senior Pharmacovigilance Officer will be varied however the key duties and responsibilities are as follows:
1. Report all adverse drug reactions from a range of sources as well as adverse events related to company sponsored clinical trials. Perform QC checks on all AEs, prepare PV agreements and handle all partner reconciliations.
2. Perform Signal Detection and management activities as well as the preparation of Periodic Safety Update Reports (PSURs) to UK and EU regulations. Ensure the successful submission of PSURs as well as the generation of metric reports.
3. Support the PV Manager with QA PV strategy. Review internal and external SOPs, contribute to the Pharmacovigilance System Master Files (PSMF), develop audit plans and write Request for Proposals (RFPs) when dealing with Vendors. Raise CAPAs and ensure the general compliance of the Pharmacovigilance team
4. Continuously maintain and enhance the company's knowledge base concerning regulations, directives and guidelines as well as assisting with compliance metrics, monthly and quarterly reports. You will act as the Local Pharmacovigilance Officer (LPO) and the UK point of contact regarding the MHRA.
ROLE REQUIREMENTS:
To be successful in your application to this exciting opportunity as the Senior Pharmacovigilance Officer we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences discipline (e.g. Pharmacology, Pharmacy, Chemistry etc.) with hands on experience working in a Pharmacovigilance / Drug Safety focused position.
2. Proven industry experience in Pharmacovigilance, ideally working directly with EU agencies with a sound knowledge of EU regulations, directives and guidelines.
3. Hands on experience of Signal detection activities, writing of PSURs and participating in audits is vital for your application.
Key Words: Pharmacovigilance | Drug Safety | Associate | Officer | Senior | PV | EU | MHRA | PSUR | Adverse Drug Reactions | ADR | MedDRA | QC Checking | Triaging | Local Safety Officer | Local Pharmacovigilance Officer | CAPA | Audit
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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