Senior Pharmacovigilance Specialist

1 semana atrás


Lisboa, Lisboa, Portugal Organón Tempo inteiro

About Organón

At Organón, we are committed to providing innovative healthcare solutions that make a meaningful difference in people's lives.

Job Title: Senior Pharmacovigilance Specialist

Job Type: Full-time

Location: Remote (Flexible)

Job Description:

Key Responsibilities:
  • Responsible for day-to-day adverse events case management, including case intake and follow-up activities in accordance with Global Pharmacovigilance procedures and country regulations.
  • 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. He/she also performs ICSR acknowledgments and reconciliation activities.
  • Responsible for 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.
  • Performs reconciliation activities for PV cases received from local operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners (as applicable) and processes the reports in accordance with local procedures/PV legislations.
  • Provides support for Patient Support Programs (PSP) and/or Market Research vendor(s) 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.

Requirements:

Essential Skills and Qualifications:
  • Minimum 1 year of industry experience in pharmacovigilance and/or regulatory affairs.
  • General knowledge of PV regulations within his/her assigned country.
  • Expertise in PV processes/activities.
  • Good communication and time management skills.

Salary:

$60,000 - $80,000 per annum

Benefits:

  • Competitive salary package.
  • Opportunities for career growth and professional development.
  • A comprehensive benefits package, including health insurance and retirement savings plan.

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