Senior Pharmacovigilance Specialist
2 days ago
We are seeking a highly skilled Senior Pharmacovigilance Specialist to join our team at Organon LLC.
The successful candidate will be responsible for maintaining high quality and compliant reporting of individual case safety reports in accordance with PV regulations.
Key Responsibilities- Perform retrospective quality review of different types of case reports, including Post Marketing Surveillance (PMS), Hospital discharge summaries, Spontaneous and Literature reports processed.
- To check accuracy of all data entered in OARS, including coding of adverse event reports, Narrative, labeling and causality, Relatedness/Expectedness assessment in compliance with SOPs and regulatory requirements.
- Participate in team meetings, training of the team, process and quality improvement, and process harmonization.
- Prepare and share quality reports with operational team, contribute to RCA/CAPA of quality nonconformance.
- Lead Quality Review Cycles (Case Assignment, Sample Review, Tracking and Finalizing cycles), facilitate Quality Review feedback between Data Entry site and ICSR Quality Review Team. Approve case corrections and revisions when appropriate.
- Bachelor's degree or master's degree in a life science/health care/pharmaceutical related field.
- Minimum of 3 years of experience in the pharmaceutical industry with a specific focus on pharmacovigilance related activities related to individual case safety reporting.
- Previous experience with Pharmacovigilance and PV system (preferably Argus) and quality review activities.
- Knowledge of PV principles, systems, and requirements in addition to PV regulations.
Organon is a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for.
We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.
Benefits- A competitive estimated annual salary range: $80,000 - $110,000
- Relocation assistance may not be available
- This position requires you to satisfy travel and credentialing requirements, including vaccination prerequisites
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