Pharmacovigilance Manager
CPL
TIPPERARY
On behalf of our client, a consultancy company, we are currently recruiting for a Pharmacovigilance Manager. The Pharmacovigilance Manager will: Support the continuous improvement of the Regulatory Pharmacovigilance system, Take a lead role in any pharmacovigilance audits and ensure colleagues are trained accordingly, Mentor staff (including new hires) on pharmacovigilance, 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 company 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 PV function in the company 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 Pharmacovigilance 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. Ability to mentor and motivate employees. Above average communication skills both written and oral, with the ability to influence at a senior level. For a full Job Spec and to apply for this role please call Linda on +353 1 2784671 or e-mail LDunne@thornshaw.com. Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671.
1520 days ago