Vacancy: Clinical Project Manager at Acorn Regulatory
As part of our ongoing growth, we are now recruiting for a new role: Clinical Project Manager.
The role will be based within the Acorn Regulatory facility at Powerstown House in Clonmel, Co. Tipperary in Ireland.
The Clinical 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 clinical function in Acorn Regulatory as required;
- Work with Clinical/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 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.
- Extensive Clinical Regulatory experience especially pertaining to clinical report writing for medicinal products and medical devices (COS & CER’s).
- Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage, understanding of the regional regulatory procedures for CTAs.
- Ability to mentor and motivate junior employees.
- 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: email@example.com