On behalf of our client, a global pharmaceutical company, we are currently recruiting for a Pharmacovigilance Associate.
The Pharmacovigilance Associate (PVA) is primarily responsible for supporting the Pharmacovigilance (PV) department in the receipt, assessment, processing and reporting of Individual Case Safety reports (ICSRs) in accordance with PV procedures and PV legislation to ensure compliance is met to Regulatory bodies, affiliates and partners in the stipulated timelines.
- Performing assessment of adverse event case reports
- Act as case owner for assigned ICSRs to ensure accurate completion of data entry (DE), data review (DR) and regulatory reporting (RR), in line with current SOPs
- The PVA acts as a product owner for allocated products, supporting the PV Scientists/PV Physicians with literature management and aggregate report preparation for their assigned products
- Maintain a high standard of case quality
- The PVA is responsible for providing a root cause analysis to the Team Lead/Case Workflow Manager for any late reporting submissions
- Assisting with reconciliation of all adverse event reports received from PV service providers, affiliates, distributors and licence partners
- Management and prioritisation of individual workload while maintaining good documentation practices (GDP)
- Act as a back-up to Team Lead
- Contribute to the development of PV training
- Assist with data entry, data review and submission of XEVMPD records
- Maintenance of the Company Product Dictionary (CPD)
- Support preparation of SOPs, WINS, product safety reviews as required
- Highlighting any safety related issues to the attention of the management team
- Keep abreast of changes to PV Legislation.
- All other ad hoc PV activity duties as required by the business needs
- Adhere to agreed Key Performance Indicators (KPIs)
- Support the continuous development and improvement of the PV department while upholding company core values.
- Life sciences/biological science graduate.
- Preferably 1 year experience in Pharmacovigilance
- Competent Medical Terminology
- Previous use of safety database desirable
- Ability to prioritise, plan and organise work with an appropriate sense of urgency based on regulatory requirements and business needs
- Be performance driven with accountability and ownership
- Communicate effectively as part of a team
- Be driven to continuously grow and develop
- Exceptional attention to detail
- Flexibility and good time management skills
- Excellent interpersonal and communication skills
For more information and to apply for this role please call Linda on +353 1 2784671 or e-mail firstname.lastname@example.org
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Www.thornshaw.com Tel: +353 1 2784671