Senior Pharmacovigilanceregulatory Affai
We are currently recruiting for a Senior Pharmacovigilance/Regulatory Affairs Advisor role. This is a permanent, full-time role, with excellent flexibility in terms of working from home. Key Accountabilities/Responsibilities: Creation & review of all clinical reports, efficacy & safety summary reports while working collaboratively with Acorn clients. Provision of internal and external technical training ensuring maintenance of company standards and QMS. Preparation of Risk Management Plans (RMPs), Signal Detection Reports, PSURs, DSURS, PBRERs etc. Assessment of suspect ICSRs reported to Acorn for reportability. Provide senior Regulatory Affairs guidance and support to the team in collaboration with the Regulatory Affairs Manager. Full assessment of internal Pharmacovigilance system. Create SOPs and maintenance of system thereafter. Review and/or creation of Clinical Evaluation Reports (CER) for Medical Device clients. Review applicable internal SOPs, provision of input and feedback for improvement of same. Work collaboratively with colleagues to share best practice and information, thus ensuring a consistent approach with Clients, Competent Authorities and internally. Builds and maintains strong relationships with different Competent Authorities to ensure ease of access and influence. Works collaboratively with other department colleagues to share best practice and information and to ensure a consistent approach with both Competent Authority & within company. Attributes/Experience required: B.Sc. in Science related discipline as minimum. A minimum of 5 years experience in Regulatory Affairs in the Pharmaceutical Industry. Strong commercial awareness & an innate ability to assess the commercial implications of decisions & advice. Be an authority on Pharmacovigilance legislation in Ireland & Europe with the ability to provide high end support as necessary. Excellent project management skills. Above average communication skills both written and oral, with the ability to influence at a senior level. Ability to mentor and motivate junior employees. Motivated self-starter with the ability to work independently. Confidence to embrace new challenges within the parameters of qualifications and experience. For a full Job Spec and to apply for this role please call Linda on +353 1 2784671 or e-mail firstname.lastname@example.org. Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Tel: +353 1 2784671.
170 days ago