Pharmacovigilance Specialist
3 semanas atrás
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- Manage day-to-day adverse events case management, including case intake and follow-up activities, in accordance with Global Pharmacovigilance procedures and country regulations.
- Process Individual case safety reports (ICSRs), including tracking and translation to English, and forward information to the Data Management Center.
- 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.
- Perform reconciliation activities for PV cases received from local operating units and contractual partners, and process reports in accordance with local procedures/PV legislations.
- Support Patient Support Programs (PSP) and/or Market Research vendor-related activities, as applicable.
- File, store, and archive safety-related and regulatory data and documentation in accordance with department and company policies and local requirements.
- 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.
- Support local PV audits and inspections, including readiness activities, and support other audits/inspections, including the development of CAPAs in response to findings/observations.
- 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.
- 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.
- Proactively identify procedural gaps and challenges and implement solutions in collaboration with all affected stakeholders.
- Support training of local company staff, distributors, vendors, business partners, including training documentation.
- 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.
- May be assigned responsibility for ensuring appropriate implementation and oversight of local Risk Minimization Measures and ARMMs.
- Liaise with the local business units to keep them apprised of safety activities and provide input on strategic decisions, with Management oversight.
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 / CertificatesA 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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