Pharmacovigilance Manager, Ukraine & Moldova

Takeda Pharmaceutical

Experience
Workhours
Qualifications
  • Prepares and maintains a local PV system and handles safety information in accordance with current valid global and local SOPs, 3rd party agreements (when applicable) and local regulatory requirements
  • Define and describe local procedures in relevant local SOPs – author and approver
  • Prepares, maintains and initiate update of a Service Level Agreement (SLA) with Pharmacovigilance Affiliate Relations (PVAR)
  • Keeps abreast of local PV legislation and notifies the PVAR of any changes
  • Informs PVAR if any changes to the territory the LOC is responsible for
  • Ensures 24/7 coverage for PV related matters in the LOC
  • Maintain LOC PV mailbox for exchange of safety information including ICSRs
  • Provide Regional Hub with monthly compliance information
  • Conducts PV training of all local PV employees,  non PV staff, all sites within the territory and external service providers optionaly
  • Collect and track adverse events / reactions from local market and report them to GPV and local Competent Authority (CA) if reportable. Perform and initiates follow-up queries on ICSRs including non-valid cases. Perform of seriousness and causality assessment on ICSRs
  • Ensures that any new or changes to products/licenses are notified to GPV, in particular to implement necessary changes to the safety database, ISIS.
  • Maintain the local list of products
  • Inform PVAR about requested changes in the Reference Safety Information (SPC, PILs, PI, etc)
  • Prepares, maintains and tests a Business Continuity Plan for PV
  • Reviews local labelling of marketed products for ICSR assessment
  • Keeps an oversight about Risk Management Plans (RMP) and risk minimization activities relevant for the territory
  • Manages local medical literature surveillance
  • Inform GPV on all local 3rd party agreements (e.g. in-licensing or out-licensing of products)
  • Review and approve 3rd party pharmacovigilance agreement
  • Reviews contracts of external service providers involved in activities where potential AEs may be reported and ensures that local internal procedures are established
  • Keeps an oversight of local activities such as investigator initiated trials, non-interventional studies, compassionate use, named patient supply, company sponsored/controlled web-sites and social media open for two way communication
  • Ensures PV audit and inspection readiness
  • Develops CAPA plans and drives local implementation
  • Participates in the annual DSO meeting
  • University degree in medicine/pharmacology
  • Excellent experience in pharmacovigilance management in international or Ukrainian company over 3 years
  • Fluent English
  • Experience in a similar position more over 3 years
  • Experienced PC user (MS Office: Word, Excel, PowerPoint)
  • Accommodation in Kiev
  • Strong analytical skills, ability to work with strict timelines in a fast moving environmental, attention to details
  • Strong PC skills (MS Office applications, especially MS Excel, Power Point; planning/analytical systems)
  • Driving licence Category B
Competencies and skills:
  • Strategic thinking
  • Negotiating skills
  • Planning and organization
  • Team player
  • Fluent English
  • Fluent Ukrainian

*LI-NK1-NEM


Schedule
Full-time
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Confirmed 10 hours ago. Posted 30+ days ago.

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