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Job DetailsWe have an exciting opportunity for a Sr PV Manager to join our supportive and growing team here in Pharmalex Finland!
The main responsibilities will include:
Set up and manage the local pharmacovigilance systemEnsure PV training of affiliate employees, service providers and Third PartiesProvision of pharmaceutical expertise in the entire field of pharmacovigilance.Case ManagementKnowledge and oversight of the entire ICSR process from intake to reporting, how this process impacts other services in SCS (aggregated reports, compliance, signalling, etc) and provide guidance to applicable teams performing these tasks.Oversight of team PV activities including ICSR reporting, reconciliations, follow up requirements, literature screening, signalling, inquiry and complaint management.Communication with regulatory authorities and clients regarding all pharmacovigilance-focused aspects.Review and approve safety update reports PSURs (Periodic Safety Update Reports), PADERs (Periodic Adverse Drug Experience Reports) DSURs (Development Safety Update Reports), risk management plans and signal detection reports required and in support of risk-benefit profiling.Writing/Review of procedural documents such as Working Instructions, SOPs, Working Procedures, Templates etc. for PharmaLex PV projects.Organize and perform training of the above-mentioned procedural documents.Preparation of and participation in internal and external PV audits/inspections.CAPA review and approval..
Several years’ experience and profound knowledge in the field of pharmacovigilance Expertise, experience and knowledge regarding relevant legislative and non-legislative guidelines on pharmacovigilanceDemonstrable ability in leading, mentoring, managing and motivation of staff.Ability to lead project teams, distribute work equally and according to team member's strengths as well as to achieve commitment according project milestones.Ability to manage internal and external (client) relationships on level of client's department heads; ability to discuss and align mid-term goals of collaboration.Very good communication skills (written and verbally); proven capability to communicate critical issues and propose appropriate (cross-divisional) solutions to decision makers. Good presentation skills.English business fluent & FinnishWhat Cencora offersBenefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.
Full timeAffiliated CompaniesAffiliated Companies:Equal Employment OpportunityCencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.
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