CV-Library
Pharmacovigilance Advisor x2
Pharmacovigilance Advisor
Are you passionate about ensuring the safety and efficacy of medications? Do you have a keen eye for detail and a commitment to quality? If so, we have an exciting opportunity for you!
Position: Pharmacovigilance Advisor – 2 openings (one at a senior level)
Type: Permanent and hybrid
We are looking for two dedicated Pharmacovigilance Advisors to join a dynamic team -one in a more senior role. As part of their mission to uphold patient safety and regulatory compliance, you will play a crucial role in the company pharmacovigilance efforts.
What You Bring:
Educational Background: A B.Sc. in Science, Pharmacy, Pharmacology, Nursing, or a related discipline is essential.
Experience: A minimum of 2 years in pharmacovigilance and quality management systems.
Commercial Awareness: You understand the commercial implications of decisions and advice.
Regulatory Knowledge: Familiarity with Pharmacovigilance legislation in Europe and the UK.
Project Management Skills: A systematic approach to tasks is key.
Attention to Detail: Meticulous record-keeping and a commitment to client satisfaction are vital.
Interpersonal Skills: Strong communication skills with the ability to influence stakeholders both internally and externally.
Self-Motivated: A proactive individual who can work independently and embrace challenges.
Confidentiality: A commitment to maintaining client confidentiality at all times.
Work Ethic: A strong work ethic is a must!
Key Responsibilities:
Adhere to the company's Quality System and Pharmacovigilance Quality System.
Process cases and ensure timely reporting of Individual Case Safety Reports (ICSRs).
Maintain global safety databases and screen literature for ICSRs and safety information.
Conduct periodic case reconciliations with clients and business partners.
draught Pharmacovigilance Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs).
Assist in GVP inspection readiness and participate in quality system continuous improvement initiatives.
Support during client audits and authority inspections.
Prepare signal detection reports, Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), and Pharmacovigilance System Master Files (PSMFs).
Contribute to the continuous improvement of Standard Operating Procedures (SOPs).
Why Joining?
Impactful Work: Be a part of a team that prioritises patient safety and compliance.
Professional Growth: Opportunity for development and advancement in your career.
Supportive Environment: Work alongside a team of passionate professionals who value collaboration and innovation.
Competitive Benefits: Enjoy a comprehensive benefits package that supports your well-being.
If you are ready to embark on a fulfilling career as a Pharmacovigilance Advisor, we want to hear from you!
Application: Please submit your CV detailing your experience and enthusiasm for this role.
Please note: Applicants must have the legal right to work in Ireland at the time of application