Lilla Vilmek

• Analyse and process reports of drug side-effects from post-marketed or clinical study sources in the safety database.
• Perform appropriate clinical assessment including the assessment of seriousness, labelling and company causality for each adverse event adhering to SOPs and other controlled documents.
• Draft notifications to the Client.
• Support analysis and quality control during the generation of Aggregated Safety Reports. and Medical Management Plan, including development of specific processes to assure consistency within the project....
• Raise query if needed within clinical database or email to sites
• Responsible for effective and efficient development of the safety section of the Safety and Medical Management Plan, including development of specific processes to assure consistency within the project
• Support analysis and quality control during the generation of Aggregated Safety Reports

Reporting:
• Prepare regulatory documentation packets and coordinate the timely completion and submission of SUSARs to health authorities, Ethic Committees, Principal Investigators based on the reporting requirements.
• Ensure compliance with regulatory reporting requirements for safety reporting.

Other PV activities:
• Complete tracking of incoming safety information.
• Ensure all relevant information concerning the safety of medical products is collected, evaluated and communicated while meeting tight regulatory deadlines and regulated timelines promptly and accurately.
• Report project status (including monthly metrics) to project/functional management.
• Enable on-boarding and train new hires.
• Participate in Client meetings.
• Assure consistency of plans with client contract and identify out of scope activities promptly and accurately.
• Report project status (including monthly metrics) to project/functional management.

• Developed comprehensive training materials and conducted workshops for junior team members to enhance their drug safety knowledge and skills.

• Led initiatives aimed at improving data quality in the company''s pharmacovigilance database, resulting in more accurate analyses and informed decision-making processes.

• Communicated with internal or external contacts to resolve issues related to case processing.

• Collaborated with physicians and other healthcare professionals to evaluate the effectiveness of treatments and diagnostic techniques.