Scientific Officer- Pharmacovigilance

Location
Dublin (City), Leinster (IE)
Salary
DOE
Posted
29 Mar 2021
Closes
19 Apr 2021
Ref
CP/JO-2103-465549
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Scientific Officer – Pharmacovigilance
On behalf of my client, I am recruiting for a Scientific Officer – Pharmacovigilance. This is a maternity leave contract.
The successful candidate will be responsible for contributing to the safety monitoring of medicines and BTO vigilance activities, to ensure all obligations and requirements are met; along with contributing to the development of the QMS for the Pharmacovigilance (PV) section, liaising with the team as necessary.
Key Responsibilities:
• Working closely with the PV Surveillance Assessor and team to ensure processing and evaluation of adverse reaction data and follow up of individual case safety reports (ICSRs)
• Working with colleagues to facilitate changes to safety reporting requirements arising from revisions to clinical trials legislation
• Contributing to the review and implementation of system upgrades, through appropriate testing and feedback on system changes and updates to associated procedures
• Liaising with and providing technical information, advice and guidance on PV matters to HPRA and other regulatory colleagues, pharmaceutical companies, relevant national and international bodies, healthcare professionals and members of the public
• Support the PV Surveillance Assessor and other colleagues by preparing and compiling PV data for review and drafting reports, including as required: database searches, EudraVigilance/WHO database searches, literature and other searches as needed
• Contributing to the review, evaluation and follow up of individual and cumulative safety data
• Coding, classification and evaluation of adverse event/reaction data, and maintaining records of in-house and archived adverse event/reaction data
• Assisting in monitoring company/sponsor compliance with PV reporting requirements
• Liaising with and providing support to other areas of the PV section
Qualifications:
• Have a third level degree in a relevant scientific or related discipline
• Relevant experience in pharmaceutical/clinical quality assurance, pharmacovigilance, compliance, clinical data management, or other related areas.
• Experience with pharmacovigilance and adverse reaction reporting/monitoring activities
• Previous experience with electronic reporting systems, clinical data management or clinical research would also be an advantage
• Knowledge of relevant European/National legislation, guidelines and reporting requirements
• Excellent communication skills with the proven ability to deliver appropriate information to the right people using a range of written, verbal and presentation skills
• Excellent data analysis skills and demonstrated initiative and problem-solving capabilities
• Proven ability to work effectively as part of a multi-disciplinary team
• Highly motivated and with the ability to manage deadlines
• Experience writing Scientific Reports would be advantageous