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.