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