Senior Manager PV Operations

Senior Manager PV Operations

Daiichi Sankyo Europe

Munich, Germany

Purpose of the function:

Lead the individual case safety report (ICSR) management and processing team at Daichi Sankyo Europe (DSE) which focuses on ICSR case handling. Performing Data Management of Clinical Safety & Pharmacovigilance (CSPV) information of ICSR from clinical trials and marketed products. Ensure regional ICSR team compliance with and support updating of global and local procedures. Oversee and support PV Operations KPIs and CAPAs related to ICSRs management together with the DSE CSPV PV Quality management team. Represents DSE CSPV ICSR and associated projects and initiatives for cross functional activities in inspection/audits relevant to ICSR related activities.

Responsibilities:

  • Ensure the local day-to-day work for ICSR collection, processing, reconciliation and reporting, including associated quality and training activities are performed to ensure regulatory timelines and global standards are met. This includes AE report intake, Case processing, Follow-up requests, ICSR reporting, ICSR quality control, SAE reconciliation, Partner reconciliation, Case processing vendor management, Workflow management.
  • Ensure that all safety reports received are processed and reported according to regulatory requirements and company procedures. Support and/or provide internal training on ICSR activities
  • Co-Lead and support global Clinical Safety & Pharmacovigilance activities such as global working groups.
  • Ensure and support regular update of working procedures in accordance with regulatory requirements and implement working procedures/ regulatory requirements for case processing
  • Manage, Communicate and provide trainings on ICSR activities, safety procedures and processes on a regular basis with case process service providers and oversees their quality of work.
  • Represents Clinical Safety & Pharmacovigilance ICSR management Group in authority inspections or audits
  • Cooperate with Safety Physicians and the Data Analyst group to coordinate case processing tasks.
  • Cooperate and support Regulatory Affairs Department with regard to safety aspects during submission and maintenance of marketing authorisations.

Requirements:

  • Bachelor’s degree at minimum required; Master, PhD preferred
  • Minimum 5 years of experience in PV with an advanced degree
  • Proven leadership record and positive attitude
  • Possesses strong PV regulation knowledge
  • International, European and PV laws
  • Experience in case management
  • Fluent business English (oral and written)
  • Excellent computer skills
  • Excellent knowledge of English
  • Highly reliable and accurate
  • Team player with analytical problem-solving skills
  • Good communication skills especially on an intercultural level
  • Ability to work with deadlines under high pressure

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

© EuroJobsites 2023

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

Newsletter | Recruit | Advertise | Privacy | Contact Us

© EuroJobsites 2023

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom