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Job Details

Senior PV Officer

Company: SciPro
Location: Harlow
Reference: SPVO01
Closing Date: 17 Aug 17
Type: Contract
Salary (£): Negotiable
Benefits:

Job Summary:

Looking for a PV Officer to join my Essez based client on an inital 6 month contract starting ASAP.

Requirements:

Pharmacovigilance

* Achievement of internal case processing targets
* Records and reports all adverse drug reactions relating to company products as per UK/EU requirements whether received from Healthcare Professionals, Competent Authorities, Medical Information or literature sources.
* Records and reports all adverse events relating to company sponsored clinical trials as per UK/EU requirements.
* Prepares expedited report and handles AE follow-up requests i.e. requests further information from healthcare professionals on all notified adverse experiences, where appropriate.
* Alerts company personnel of any possible adverse changes to the benefit-risk profile of company products and provides relevant information as required to facilitate an assessment.
* Distribution of the Pharmacovigilance team's daily workload.



Periodic Safety Update Reports (PSURs)

* Generation of PSURs in line with UK/EU requirements.
* Submission of all PSURs as per UK/EU requirements.
* Maintains PSUR schedule.
* Diarising PSUR Data Lock Points and submission cycles in order to coordinate the submission of all Periodic Safety Update Reports (PSURs) as per UK/EU requirement.



Pharmacovigilance Systems

* Maintenance and monitoring of existing pharmacovigilance systems in line with UK/EU requirements.
* Processes and reviews all AE information and maintains the company databases, ensuring all entries and coding systems are correct.
* Reconciliation of ADR and MI reporting.
* Acts as deputy Local Pharmacovigilance Officer (LPO) and acts as the UK point of contact regarding MHRA and group (STADA) pharmacovigilance matters.



Company compliance with MHRA/EU pharmacovigilance regulations, directives and guidelines

* Continuously maintains and enhances the company knowledge base concerning the regulations, directives and guidelines that influence pharmacovigilance requirements and advises on the implications thereof.
* Ensures all Company and regulatory timeframes are met for the processing and reporting of safety information.
* Train all company and non-company personnel, where applicable, in pharmacovigilance requirements.
* Compilation of compliance metrics, monthly report and quarterly reports.



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Contact Information:

Address:  Head Office
4th Floor, 150 Leadenhall Street, London
EC3V 4TE
England
Tel:  +44(0)203 327 3072
Website:  Visit Our Web Site

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