
PV Professional
3 weeks ago
- Literature Review:Participate in literature review activities by designing and implementing comprehensive search strategies using databases such as Embase, Medline, PubMed, and Ovid.
- Regulatory Impact Assessment:Assess the impact of regulatory changes on current processes and contribute to process simplification.
- Pharmacovigilance Support:Support pharmacovigilance teams in case processing, training, quality assurance, audits, and inspections.
- Consulting & Knowledge Management:Act as a consultant or Single Point of Contact (SPOC) for case-related activities and maintain a knowledge repository of process updates and regulatory changes.
- Effective Communication:Maintain effective communication with internal departments and external stakeholders to ensure process transparency.
- Data Analysis & Quality:Analyze quality data for trends and prepare the team for process stabilization while ensuring regulatory compliance by meeting key performance indicators.
- Independent Initiatives:Operate independently and make valuable decisions in response to dynamic regulatory requirements.
- Training & Mentoring:Conduct workshops, training sessions, and other interactive activities to educate the team on process improvements and error trends. Mentor new hires in case processing and evaluate their progress.
- Additional Tasks:Perform other tasks as assigned by the direct manager.
Qualifications
- Educational Background:Bachelors or higher degree in life sciences, pharmaceutical, or healthcare fields (e.g., B. Pharmacy, M. Pharmacy, Pharm D, BDS).
- Experience:Minimum of 3-4 years in pharmacovigilance with a focus on literature review processes in Individual Case Safety Reports (ICSR).
- Expertise:Solid knowledge of pharmacovigilance concepts, regulations, and procedures, along with advanced proficiency in Microsoft Office.
- Skills:Excellent communication (written, verbal, and non-verbal), interpersonal, analytical, and problem-solving skills. Ability to adapt to shifting team priorities.
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