Regulatory Affairs and Pharmacovigilance Manager, Clinical
|Contact Name:||Larry O’Leary|
Our client, a Pharmaceutical company, now require a Regulatory Affairs and Pharmacovigilance Manager as a technical subject matter expert for product / clinical development projects and also to lead, develop and motivate their team to achieve targets in a dynamic fast paced environment.
The successful candidate will manage the regulatory team and lead assigned regulatory projects in early stage development including management of budget, time-lines and submission planning.
Responsibilities of Reg Affairs and Pharmacovigilance Manager, Clinical Development:
Mentor staff (including new hires) on pharmacovigilance, clinical processes and interactions - both internally and externally.
Schedule, delegate and monitor processes & workflows.
Lead role in any pharmacovigilance audits and ensure colleagues are trained accordingly.
Lead continuous improvement of the Regulatory Pharmacovigilance system.
Ensure the timely and accurate processing of ICSRs, monitoring the AEs case processing and 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 scope out and implement process improvements in line with company business plan and management team.
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 the company as required.
Requirements for Reg Affairs and Pharmacovigilance Manager, Clinical Development:
BSc in Life Science discipline. MSc or higher is preferred.
10+ years' experience of cross-functional Regulatory Affairs in the Pharmaceutical Industry.
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 and experience of eCTD submissions.
Excellent project management skills with the ability to oversee multiple projects simultaneously.
Ability and experience to manage a diverse team of professionals.
A proven track record in communicating with top level management and competent authorities.
Strategic thinking as well as hands-on experience with different registration procedures.
Excellent communication skills both written and oral, with the ability to influence at a senior level.
Please contact Larry on +353 1-2302400 / email@example.com
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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Key words; Regulatory Affairs, Regulatory Compliance, Pharmacovigilance, Marketing Authorisations, Clinical Development, New Product Development, Pharmaceuticals, Biotech, Biopharma, Medical Devices, Dublin, Leinster, Munster, Europe, Ireland.