Senior Pharmacovigilance Officer
|Job Title:||Senior Pharmacovigilance Officer|
|Contact Name:||Alex Young|
|Job Published:||February 22, 2017 09:41|
Objective - To head up the PV team to perform activities relating to pharmacovigilance for all company products, provide training in matters of drug safety & medical/product information and ensure that the company is compliant with relevant MHRA/EU regulations, directives and guidelines.
Key accountabilities -
- 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.
- 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.
Person specficiation -
- A Life Science degree or equivalent.
- Relevant experience in the pharmaceutical industry.
- Experience in EU pharmacovigilance within either a research and development or established products environment.
- Experience working directly with EU agencies.
- Sound knowledge of applicable EU Regulations, Directives and Guidance.
- Exceptional organisational skills - ability to prioritise effectively.
- Excellent oral and written communication skills - able to be effective at all levels.
- Good interpersonal skills - ability to work with cross-functional teams.
- MS Office applications; including Excel; PowerPoint; Project; and Word, is required.
- Accuracy and attention to detail.
- Ability to deal with information.
- Ability to challenge scientific arguments.
- Ability to work under own initiative - proactive problem solving approach.
- Team player with a positive 'can do' attitude.
- Good understanding of business needs.