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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