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Senior Pharmacovigilance Officer

Senior Pharmacovigilance Officer

Job Title: Senior Pharmacovigilance Officer
Contract Type: Contract
Location: Berkshire
Industry:
Salary: Negotiable
Start Date: ASAP
Reference: SPV1
Contact Name: Alex Young
Contact Email: a.young@sciproglobal.com
Job Published: February 04, 2017 11:00

Job Description

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.

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.

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.