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.