
Physician-Medical Evaluation Specialist
1 week ago
We are seeking a skilled Medical Assessor to oversee and provide medical input to benefit-risk assessment activities. As a key member of our team, you will be responsible for data analysis, report preparation, and signal detection.
Main Responsibilities:
- Conduct quality control of medical assessments of individual case safety reports.
- Contribute to the scheduling of aggregate reports and other safety-related documents.
- Provide medical input and review of Medical Assessment deliverables.
- Conduct peer quality review of aggregate reports.
- Support PV Scientists in ensuring all aggregate reports are prepared, reviewed, and submitted in line with regulatory requirements.
- Signal evaluation: Validate potential signals and ensure appropriate actions are taken for confirmed signals.
- Summarize findings and present to senior management.
You will work within our PV team and cross-functionally with key stakeholders, including Clinical, Regulatory Affairs, Medical Affairs, Commercial Teams, and Business Units.
Process Improvement / StandardizationAs part of our process improvement initiatives, you will participate in promoting internal audit and regulatory inspection readiness.
QualificationsWe require an MBBS degree preferably with MD and at least 5 years of relevant PV experience.
Desired Skills & Competencies:
- Good working knowledge of PV regulations.
- Strong data analysis and report writing skills.
- Excellent teamwork and interpersonal skills.
- Strong problem-solving and decision-making skills.
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