PV Professional

• 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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