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.

PV Professional