A leading global biopharmaceutical company is advertising a vacancy for a Pharmacovigilance Specialist with their company in the UK. The organisation is at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world. This is an exciting opportunity to work with a leading company that operates in over 140 companies.
- Overseeing adverse experience case management within the country(ies) covered by the operation, including case intake and follow-up activities in accordance with Global Safety procedures, the review of local literature as per the company's procedure and country regulations, and health authority submissions of cases in accordance with Global Safety procedures and health authority requirements.
- Reconciling adverse events reports received from other company operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners, as applicable
- Filing, storing, and archiving safety-related data in accordance with the company's policies and local requirements.
- Complying with local PV regulations, company policies and procedures, and Global Safety procedures at the country level.
- Participating in individual case safety report compliance activities and takes the necessary corrective actions locally for the late reporting within the country(ies) covered by the country operation.
- Assisting in the preparation for audits/inspections for their country/territories and participating in the audit and/or inspection.
- Identifying and communicating potential safety issues to PV Country Lead.
- Assisting in the delivery of training and mentoring PV staff, as applicable.
- Assisting in the delivery of training to PV staff and customer facing non-PV staff (e.g., Sales Reps, Medical Information, etc.) and distributors/vendors/business partners in the country(ies) within scope.
- Completing and documenting required PV training within the required timelines.
- Performing other activities as requested by the PV Country Lead.
- Liaising with Data Management Centres and Global Safety Global Case Management colleagues at HQ.
Skills and Requirements:
- A health, life science, or medical science degree or equivalent by education/experience.
- A minimum 1 year of pharmaceutical industry experience.
- An awareness of Pharmacovigilance regulations within assigned country(ies).
- Knowledge of pharmacovigilance systems & requirements.
- Knowledge of pharmacovigilance principles, concepts, practices & standards.
- Knowledge of the local country(ies) pharmacovigilance regulations & obligations.
- Awareness of Good Clinical Practice concepts.
- Proficiency in Good Documentation Practices.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Ronni Hartgen at +44 2038000814 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
Haan (42781), Germany
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