Vacancy: Pharmacovigilance Manager at Acorn Regulatory
As part of our ongoing growth, we are now recruiting for a new role: Pharmacovigilance Manager.
The role will be based at the Acorn Regulatory facility at Powerstown House in Clonmel, Co. Tipperary in Ireland.
The Pharmacovigilance Manager will:
- Support the continuous improvement of the Acorn Regulatory Pharmacovigilance system;
- Take a lead role in any pharmacovigilance audits and ensure colleagues are trained accordingly;
- Mentor staff (including new hires) on pharmacovigilance and clinical processes and client interactions;
- Organise and monitor processes and workflows;
- Accountable/responsible to ensure the timely and accurate processing of Individual Case Safety Reports (ICSRs) for client projects, which includes assessment of suspect ICSR’s reported to Acorn for reportability, monitoring the adverse event (AE) case processing, adverse event reporting to regulatory authorities, global compliance, inspection readiness, quality management, pharmacovigilance training;
- Responsible for the preparation/support with the preparation of Risk Management Plans (RMP’s), Signal Detection Reports, Periodic Safety Update Report’s (PSURs) etc;
- Analyse data, identify performance trends and take action to improve and sustain performance levels;
- Identify areas for process improvement and implement process improvements as approved by the Managing Director;
- Monitor staff to ensure compliance and adherence to regulations;
- Inform clients/management of relevant issues and potential concerns to a product’s safety;
- Accountable for ensuring that any identified corrective actions are implemented in a timely manner;
- Support quality, regulatory and other personnel outside of the PV function in Acorn Regulatory as required;
- Work with PV team to develop their performance objectives and monitor their performance against the objectives.
In terms of experience and academic achievement. the Clinical Project Manager will have:
- BSc (MSc or higher preferred) life sciences, or related discipline as a minimum.
- Strong commercial awareness & an innate ability to assess the commercial implications of decisions & advice.
- 7-10 years related experience within Pharmaceutical Regulatory Affairs.
- Extensive experience with global Pharmacovigilance legislation.
- Ability to mentor and motivate colleagues.
- Above average communication skills both written and oral, with the ability to influence at a senior level.
If you would like to have a discussion about the Clinical Manager role then please contact Brian Cleary at Acorn Regulatory on 052 61 76 706. If you would like to send your CV then please email it to firstname.lastname@example.org