
Expert Pharmacovigilance Leader
2 days ago
As a Project Lead in the field of Pharmacovigilance, you will be responsible for overseeing various projects related to adverse event reports.
- Direct and coordinate teams involved in pharmacovigilance projects to ensure timely completion and compliance with regulatory requirements.
- Maintain up-to-date knowledge of safety database conventions and client-specific databases.
- Collaborate with internal and external partners to reconcile safety database discrepancies.
- Monitor project workflows to meet deadlines and ensure data quality.
- Develop and deliver safety presentations to stakeholders.
- Contribute to the development of departmental Work Instructions (WIs) and Standard Operating Procedures (SOPs).
- Ensure that ICSR submissions are compliant with US and international regulations.
- Understand the scheduling of regulatory reports within the safety database.
- Process cases using Argus, handling solicited, literature, spontaneous, and other types of cases.
- Generate status reports, ensuring data accuracy and quality.
Requirements:
- Pharmaceutical or Pharm D degree.
- Minimum 10 years of experience in Pharmacovigilance Safety.
Benefits: This role offers an opportunity to work on challenging projects, develop skills, and grow professionally in a dynamic environment.
Job Requirements: The ideal candidate should have strong leadership and communication skills, as well as the ability to analyze complex data and make informed decisions.
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