Senior Pharmacovigilance Officer |Negotiable
Pharma & Science
Permanent
South East

Senior Pharmacovigilance Officer

Additional Information

Location: High Wycombe

Salary: £50,000

Hours: Monday to Friday 37.5hpw

Job Type: Permanent

Purpose of the role

The Senior Pharmacovigilance Officer is responsible for supervising and quality checking the collection, processing, reporting and following up of pharmacovigilance reports. In addition, they participate in regular signal detection/safety review activities, prepare periodic reports and Risk Management Plans (RMPs), assist with regulatory intelligence and provide training in pharmacovigilance activities.

Main Responsibilities and Duties

  • Participate in regular signal detection/safety review activities
  • Preparation of periodic safety reports
  • Preparation of RMPs
  • QC the assessments of the outputs from world-wide literature searches and evaluate them for ICSRs or relevant safety information on the company products
  • QC the triage, processing and follow up all ICSRs for all company products in accordance with applicable regulations, SOPs and safety data exchange agreements
  • Assist with the preparation of SDEAs
  • Provide training in pharmacovigilance activities to other team members
  • Assist with the preparation, review and update of the pharmacovigilance SOPs
  • Develop in-depth knowledge about the legislation, regulations and guidance related to pharmacovigilance
  • Develop scientific and technical product knowledge
  • Any other duties or projects as requested by the line manager commensurate with the grade and level of responsibility for this role, for which the incumbent has the necessary experience and/or training

Experience and Qualifications

Requirements

Essential

Desirable

Educational Level

University Degree in Medical/Biological/Life science or related scientific field

Experience

Minimum 4 years in pharmacovigilance, including participating in signal detection activities

Professional Qualifications

MSC / Post graduate Diploma in PV qualification

Knowledge

Good understanding of EMA GVP Modules

Knowledge of PV regulations outside of the EEA

If you are applying for the first time, please complete all fields below

Already registered with Sensible Staffing? Just enter your name, contact number and email.

attach
attach

Do you know someone who you think will be ideal for this position?

Complete the simple form below to send these details to your friend.

Sensible Staffing are fully committed to protecting any personal information that you choose to share with us via our website or through any means of correspondence.

What information do we collect?

We will collect and retain any personal data that you choose to send us using the online forms on our website. This information will only be used in accordance with our privacy policy and to provide you with a service or to answer your enquiry.

Sensible Staffing is part of the Pario Group of companies. At no stage will we disclose your information to a third party company outside of the Pario Group of companies and will use the appropriate security measures to ensure that all data remains private.

This also applies to any correspondence made by fax, phone or email.

Website Statistics

We track all visits to our website so that we can monitor usage and preferences to help us provide a better service and online experience for our users. Information we collect relates to referral websites, search engines and your personal IP address. We do not use this information to identify you as an individual and you will remain anonymous.

Cookies

Cookies are small files stored within your web browser from our website. Cookies do not collect or contain any personal information about you nor do they allow us to access your computer in any way, shape or form.

We use cookies to identify website usage and for statistical and analytical purposes only. All information is collected lawfully and in accordance with the Data Protection Act 1998.

Your Rights

Please note that in agreeing to share these details you have not forfeited your rights as outlined under the Data Protection Act 1998.