Pharmacovigilance Specialist

3 semanas atrás


Lisboa, Lisboa, Portugal Organon Tempo inteiro
Job Description

We are seeking a highly skilled Pharmacovigilance Specialist to join our team at Organon. The ideal candidate will have a strong background in pharmacovigilance and regulatory affairs, with excellent communication and time management skills.

Responsibilities
  1. Manage day-to-day adverse events case management, including case intake and follow-up activities, in accordance with Global Pharmacovigilance procedures and country regulations.
  2. Process Individual case safety reports (ICSRs), including tracking and translation to English, and forward information to the Data Management Center.
  3. Execute local PV processes and activities in alignment with PV systems and their associated Quality Management System, following department SOPs, company Policies and Procedures, and country legislation.
  4. Perform reconciliation activities for PV cases received from local operating units and contractual partners, and process reports in accordance with local procedures/PV legislations.
  5. Support Patient Support Programs (PSP) and/or Market Research vendor-related activities, as applicable.
  6. File, store, and archive safety-related and regulatory data and documentation in accordance with department and company policies and local requirements.
  7. Act in full compliance with global and local SOPs and report any deviations or compliance concerns immediately, assisting in preparing necessary corrective actions and preventative actions (CAPAs) locally for non-compliance issues.
  8. Support local PV audits and inspections, including readiness activities, and support other audits/inspections, including the development of CAPAs in response to findings/observations.
  9. Participate in and support audits of contractual partners/vendors, as necessary, and may be trained and assigned responsibility to conduct qualification and ongoing audits of vendors and perform due diligence activities for local country licensing agreements.
  10. Assist in developing local procedures, in compliance with regional and global standards, for the department, to ensure quality PV data and evaluate processes for potential improvement in efficiency and effectiveness.
  11. Proactively identify procedural gaps and challenges and implement solutions in collaboration with all affected stakeholders.
  12. Support training of local company staff, distributors, vendors, business partners, including training documentation.
  13. May be assigned responsible for ensuring PV language is included in local agreements and ensuring maintenance of BDLM with respect to local and regional contracts.
  14. May be assigned responsibility for ensuring appropriate implementation and oversight of local Risk Minimization Measures and ARMMs.
  15. Liaise with the local business units to keep them apprised of safety activities and provide input on strategic decisions, with Management oversight.
Experience

A minimum of 1 year of industry experience in pharmacovigilance and/or regulatory affairs is required, with a general knowledge of PV regulations within the assigned country and expertise in PV processes/activities.

Education / Certificates

A health, life science, or medical science degree or equivalent by education/experience is required, with fluency in English (written and spoken) and proficiency in local language.


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