Pharmacovigilance Officer

Location
Berkshire
Salary
Competitive
Posted
21 Jul 2017
Closes
18 Aug 2017
Ref
J4195
Contact
Chris Sowden
Contract Type
Permanent
Hours
Full Time
Hyper Recruitment Solutions are currently looking for a Pharmacovigilance Officer to join a leading Pharmaceutical company based in the Berkshire area. As the Pharmacovigilance Officer you will be responsible for all activities relating to Pharmacovigilance for company products, ensuring compliance with relevant MHRA/EU regulations and guidelines.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Pharmacovigilance Officer will be varied however the key duties and responsibilities are as follows:

1. Recording and reporting all adverse drug reactions relating to company products and company sponsored clinical trials, as per UK/EU requirements. You will prepare expedited reports and handle adverse event (AE) follow up requests, liaising with healthcare professionals where appropriate.

2. You will alert company personnel of adverse changes to the benefit-risk profile of company products providing relevant information as required to facilitate an assessment. This will involve conducting weekly literature searches on AE's or safety information relating to company products.

3. Act as the Deputy Local Pharmacovigilance Officer as the UK point of contact regarding Pharmacovigilance matters, assisting in the generation of PSUR's and other safety documentation, as well as maintaining appropriate PV systems in line with UK/EU requirements.

4. You will maintain and monitor the company knowledge base of UK/EU regulations that influence Pharmacovigilance requirements, ensuring timeframes are met for processing and reporting of safety information.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Pharmacovigilance Officer we are looking to identify the following on your profile and past history:

1. Relevant degree in a Life Science discipline or equivalent.

2. Proven industry experience in the Pharmaceutical industry in a Pharmacovigilance function adhering to EU guidelines.

3. A working knowledge and practical experience with EU regulations, guidelines and directives in a R&D or established products environment.

Key Words: Pharmacovigilance | GVP | GCP | GLP | GDP | EU Pharmacovigilance | QA | Quality Assurance | Compliance | PV | SOP's | PSUR's | Pharmacovigilance Site Master File (PSMF) | Audit | Internal Audit | External Audit | Vendors | Third Parties | New Products | Development | MHRA | CAPA | Inspection | Self-inspection | PV QA | Adverse Events | LPO |

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant 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 processionals and scientists. We look forward to helping you with your next career moves.