Global Pharmacovigilance Specialist
Há 1 mês
Job Summary
We are seeking a highly skilled Global Pharmacovigilance Specialist to join our team at Organon. As a key member of our Pharmacovigilance department, you will be responsible for the day-to-day management of adverse events case management, including case intake and follow-up activities in accordance with Global Pharmacovigilance procedures and country regulations.
Key Responsibilities
- Responsible for the intake of cases received from designated points of contact, vendors, and business partners for Individual Case Safety Reports (ICSRs), including tracking and translation to English and forwarding of information to the Data Management Center.
- Performing ICSR acknowledgments and reconciliation activities.
- Execution of 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.
- Reconciliation activities for PV cases received from local operating units and contractual partners, and processing reports in accordance with local procedures/PV legislations.
- Supports Patient Support Programs and/or Market Research vendor-related activities, as applicable.
- Files, stores, and archives safety-related and regulatory data and documentation in accordance with department and company policies and local requirements.
- Acts in full compliance with global and local SOPs and reports any deviations or compliance concerns immediately, assisting in preparing necessary corrective actions and preventative actions (CAPAs) locally for non-compliance issues.
- Supports local PV audits and inspections, including readiness activities, and supports other audits/inspections, including the development of CAPAs in response to findings/observations.
- Participates in and supports audits of contractual partners/vendors as necessary, may be trained and assigned responsibility to conduct qualification and ongoing audits of vendors and perform due diligence activities for local country licensing agreements.
- Assists in developing local procedures for the department, to ensure quality PV data, and evaluates processes for potential improvement in efficiency and effectiveness.
- Proactively identifies procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders.
- Supports 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.
- Liaises with local business units to keep them apprised of safety activities and provide input on strategic decisions, with Management oversight.
Requirements
- Minimum of 1 year of industry experience in pharmacovigilance and/or regulatory affairs.
- General knowledge of PV regulations within the assigned country and be an expert in PV processes/activities.
- Good communication and time management skills.
- Health, life science, or medical science degree or equivalent by education/experience.
- Fluent in English (written and spoken) while proficient in local language.
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