Job Description

Key role responsibilities:

  • Acting as contractual partners’, 24/7 local contact person for pharmacovigilance at local level, where legally required.
  • Ensuring the survey and monitoring of national pharmacovigilance regulations and notifying Client's contractual partners about the changes, if any, on agreed basis.
  • Ensuring successful communication with local Competent Authorities and Client's contractual partners in reasonably timely manner.
  • Ensuring compliance with processes for proper collection, duplicate check, processing, accurate translation, quality control (at least second self-control), data entry into database, documentation, reporting and follow-up of all safety reports for all Client's contractual partners' products within agreed timelines following Client's or contractual partners' procedures.
  • Collection and processing of safety information at local level received from solicited sources organized by Client's contractual partner, including Clinical Trials.
  • Collection and processing of any medical enquiry/inquiry/answer received via phone/e-mail/fax or by other means from any source for assigned project(s).
  • Ensuring weekly monitoring and/or monthly quality control of local literature review in relation with Client's contractual partners' products, where applicable.
  • Ensuring that reconciliation process of identified safety information is in place and performed regularly with Client's contractual partners and stakeholders.

Key experience, required skills and competencies:

  • Preferable education of Science in health-related field.
  • At least 3 years PV experience.
  • Excellent knowledge of English language, both oral and written.
  • The ability to work independently and as a part of a team
 
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Contact

Anastasia Soldatkina
+7 495 935-86-06