Pharmacovigilance Manager - Signal Management (m/w/d)

We have a three month contract role for a Pharmacovigilance Manager/Signal Manager, based in Basel.Duties:Support the integration of local signal detection and management requirements into the global processDefine and oversees the long-term strategy to ensure that they maintain their world class leading position in automated signal detection and evaluation.Lead and manage a team of external service providers who are accountable for detecting and analyzing technical signals from post-marketing surveillance in the signal management tool for all products, the group companies or the partners (for which an agreement is in place) where the company is the global safety database holder.Oversee and ensure maintenance of all the MedDRA Queries which are used by Patient SafetyDrive the development and implementation of efficient workflow processes for the Safety Management Team (SMT). This includes the timely update of Business Guidance Documents and SOPs accordinglyEnsure that all new relevant medical safety signals originating from signal review or analyses from external Health Authority databases are adequately communicated to the respective Safety Lead for further escalation to the SMTPartner with Safety Leads who present safety signals to various internal and external boardsReview of Safety Signal sections of License partner agreements.Ensure timely and accurate communications of signals to license partners as per PVA and to PS countriesSupport the development and customization of signal detection and management software so to contribute to it is compliance with all applicable regulatory requirements. If required, contribute to linking the tool with appropriate regulatory information, so that its outputs can be used for downstream activities (e.g. addendum to clinical overview, presentations at Signal Review Team (SRT), SMT, Medical Safety Review Board (MSRB) and company Porfolio Stewardship Board (SPSB) meetings, aggregate reports)Develop new approaches (including policy, methodology, process improvements) for signal detection in Safety Signal software. Contribute to the development and customization of the tool having in mind how it can be used to integrate AI solutions in the signal management processProvide expert guidance in the development of all relevant aspects of signal detection strategy using post-marketing safety databasesEnsure the signal management tools support the required KPIs for signal detection and managementDevelop metrics for and ensure compliance with business rules of signal review and provide a periodic compliance report to Patient Safety leadershipRepresent the company on external working groups related to Safety Signal ManagementLead talent-pipeline, onboarding, training and mentoring activities for new membersLead audits and inspections as a SME for Safety Signal ManagementRequirements: Eligible to work in SwitzerlandBachelor of Science in Pharmacy /Bachelor of Science in Nursing /PharmD/PhD in relevant field or Medical Degree (MBBS or MD) requiredAt least 6 years’ experience in pharmacovigilance operations, including some hands-on experience in performing signal detection and management. Additional hands-on experience in the preparation of aggregate reports, case processing, and risk management plans is a plusExcellent understanding ICH GCP, GVP guidelines, local pharmacovigilance regulations and medical terminologyExcellent understanding of signal detection process; understanding on upstream and downstream processes is a plusAttention to detail, quality focused and ability to identify process interdependenciesStrong organizational and project management skillsUnderstanding of signal detection statistical methodologyExcellent communication (written and verbal) and presentation skillsStrong computer skills including, but not limited to, creation of spreadsheets, templates, presentations and working with and development of safety databases/applications/software.Ability to work independently, under pressure, demonstratingn initiative and flexibility through effective innovative leadership abilityExperience with PV audits and inspections and writing and implementation of CAPAProblem solving and strong negotiation and conflict management skillsFluency in English. Knowledge of other languages desirableSome understanding of how large language models work, knowledge of regulations on the use of AI in healthcare and, more specifically, in pharmacovigilance (e.g. CIOMS XIV, EU AI act).