Medical Safety Expert

1 week ago

Cork, Cork, Ireland beBeepharmacovigilance Full time €60,000 - €70,000
About the Role

The Pharmacovigilance Department is seeking a skilled Pharmacovigilance Advisor to join their team on a permanent full-time contract.

Flexibility and hybrid working arrangements are available, allowing for remote work from home combined with onsite attendance in offices.

  • Key Accountabilities & Responsibilities:
  • Adhere to Acorn Quality System and Pharmacovigilance Quality System standards.
  • Process cases and report ICSRs timely, maintaining global safety databases.
  • Screen local and global literature for ICSRs and Safety information.
  • Conduct periodic case reconciliations with clients and business partners.
  • Draft PVAs and SDEAs, driving them to finalization with stakeholders.
  • Assist with GVP inspection readiness activities.
  • Investigate non-conformances and manage CAPA initiatives.
  • Support team with Pharmacovigilance compliance activities, KPIs, and metric management.
  • Engage in quality system continuous improvement initiatives.
  • Support company during client audits and authority inspections.
  • Prepare signal detection reports, RMPs, PSURs, and PSMFs.
  • Continuously improve SOPs.
Attributes & Experience Required
  • Bachelor's degree in Science, Pharmacy, Pharmacology, Nursing, or related discipline.
  • Minimum 2 years' experience in pharmacovigilance and quality management systems.
  • Commercial awareness and ability to assess commercial implications.
  • Awareness of Pharmacovigilance legislation in Europe and UK.
  • Strong project management skills and attention to detail.
  • Excellent interpersonal and communication skills.
  • Motivated self-starter with independence and confidence.
  • Strong work ethic and discretion.
  • Candidates must have legal right to work in Ireland at application time.
What We Offer

We offer flexibility and hybrid working arrangements, allowing for remote work from home combined with onsite attendance in offices. This role provides an opportunity to work with a talented team and contribute to the success of our organization.

About Us

We are a dynamic organization dedicated to excellence in Pharmacovigilance. Our team is passionate about delivering high-quality services and making a positive impact in the industry.

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