Senior Pharmacovigilance Officer
Mary Tilston at CK Clinical is recruiting for a permanent Senior Pharmacovigilance Officer to be based in Surrey, working for a multi national pharmaceutical company.
Your main responsibilities in this role will be to:
- Ensure effective and on time processing of all pharmacovigilance data received in the department to meet internal and external timelines.
- Be responsible for reconciliation processes for case exchange between all third parties.
- Assist the Pharmacovigilance Manager/Pharmacovigilance Head with general pharmacovigilance duties. This will include management of PSuRs, Safety data exchange agreements, third parties performing PV work, patient support programmes, social media, market research, Risk Management, and creating and updating local Standard Operating Procedures
- Prioritise and manage individual workload to ensure that corporate and regulatory timelines are met for the reporting of Pharmacovigilance data.
- Ensure that all processes and data are kept in an inspection and audit ready condition at all times.
- Ensure the smooth running of the pharmacovigilance department with respect to management and processes in the absence of the Pharmacovigilance Manager.
- Perform regular monitoring of the UK safety data in order to identify trends and potential safety issues.
- Be pro-active in follow-up of cases and liaison with the Pharmacovigilance Manager and Corporate safety teams where necessary
- Increase and maintain in-depth knowledge of all safety issues relating to the company products in the UK.
- Develop and maintain an active interface with internal colleagues such as sales, marketing, medical information, Quality, regulatory, clinical studies unit and legal to ensure that they are kept informed of relevant safety issues.
- Ensure all communication received by PV from regulatory agencies (e.g. MHRA) are answered in a complete and timely manner.
- Keep up to date with Pharmacovigilance regulatory requirements and developments.
- Assist with Pharmacovigilance training of non pharmacovigilance company personnel.
- Mentor other pharmacovigilance staff and assist in their development and training.
- Be required to use own initiative to organise and prioritise workload to ensure Regulatory and corporate requirements for transmission of data are met.
- Work with the Pharmacovigilance Manager, Pharmacovigilance Officers and team assistant to ensure smooth workflow within the department.
- Ensure comprehensive follow up and tracking of all pharmacovigilance reports until case closure.
You are required to have the following qualifications, skills and experience:
- Life science degree or Qualified Health Professional (e.g. pharmacy technician, pharmacist, nurse).
- Substantial work experience in Drug Safety, pharmacovigilance.
- Strong understanding of the principles of Pharmacovigilance.
- Attention to detail and good organisational/analytical skills/time management skills.
- Ability to recognise potential issues and propose solutions (problem solving).
- Familiarity with use of Pharmacovigilance databases.
- Good oral and written communication skills.
- Good presentation skills.
If you are employed by this client you will be joining a global pharmaceutical company based in Surrey. Benefits include:
- Competitive salary
- Company bonus
- Competitive company benefits
For more information or to apply for this Senior Pharmacovigilance Officer position please contact Mary Tilston on +44 (0)1438 768717 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now.
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL30624 in all correspondence.