Nune Azaryan Dermenjian MD

• Monitor adverse events and safety signals reported by healthcare providers, patients, and literature sources for the Covid-19 Janssen vaccine, ensuring timely detection and assessment of potential risks to inform safety surveillance strategies at Janssen, Johnson & Johnson.
• Monitored globally developed Covid-19 vaccines based on aggregator and scheduled searches.
• Perform ad hoc comprehensive Literature Review and PSUR updates as requested.
• Provide a summary report of the review to the client pharmaceutical company.
• Conduct regular meetings with key stakeholders within Johnson & Johnson to provide updates on Covid-19 Vaccine Safety Surveillance findings and recommendations for further actions.
• Collaborate with cross-functional teams to analyze and interpret safety data from clinical trials and post-marketing surveillance, providing valuable insights to inform regulatory decisions and ensure the continued safety of the Covid-19 Janssen vaccine.

• Team member's support in various pharmacovigilance activities project monitoring and management
• Implement and oversee continuous training programs to maintain team members' knowledge and skills up-to-date with the latest pharmacovigilance regulations and industry best practices.
• Collaborate with cross-functional teams to implement innovative pharmacovigilance strategies that enhance patient safety and optimize regulatory compliance.
• Lead the development and implementation of innovative solutions to enhance pharmacovigilance team efficiency and productivity, ensuring timely and accurate completion of tasks.
• Develop and implement strategies to effectively manage team members' workload and priorities, ensuring efficient and timely completion of pharmacovigilance tasks and projects

Product Literature Review

· Perform routine Literature Review for detection of Drug Safety Signals

· Perform ad hoc comprehensive Literature Review for designated safety signal as requested

· Review, analyze and develop scientific and medical conclusions based on medication reference documents

· Provide a summary reports to the client pharmaceutical company

· Routine literature review using Empirica database and adverse event trend analysis

· Routine literature review and detection of manufacturing errors and various product complains

Case/Case Series Reviews

· Review, analyze and develop Individual Case Safety Report (ICSR), narrative line listing data

· Risk Management Plans (RMPs)- Scheduled Reports/Safety Updates (i.e. PSURs/PBRERs, DSURs)

· Ad-hoc Requests/Reports

· Labeling Update

· Review of adverse events data relative to a potential manufacturing deviation

Aggregate Data Reviews

· Support signal evaluation and data review

· Review of safety database including a detailed review of relevant individual records in support of signal evaluation

· Prepare signal evaluation summary in the form of a Safety Risk Evaluation and Recommended Action Plan

· Analyze data in client sponsored clinical trials, medical literature and post marketing safety data

· Requests for additional data following initial aggregate data review

· Support to project deliverable RMPs, HA safety queries, label updates, scheduled and ad- hoc safety reports/safety updates

· Search and summarize the background information required for signal evaluation

· Presentation of findings in client's Risk Management Committee meetings for drug label updates

• Team member's support in various pharmacovigilance activities Project monitoring and management
• Resolution of team concerns ensuring best performance plan.
• Develop and implement strategies to foster a culture of continuous improvement within the pharmacovigilance team, encouraging collaboration and innovation to drive efficiency and quality in project outcomes.

• Examine new patients and recommend the best treatment plan
• Monitor the condition of patients and advise on further prognosis
• Organize and review departmental presentations
• Assist the chief of staff in conducting scientific research work
• night shift responsibilities
• Work in the emergency care department and provide immediate assistance to patients.

• Develop research results in compliance with Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs)
• Format research results as prescribed in regulatory guidelines
• Assist to MW Lead in preparing the Clinical Study Report (CSR)
• Prepare draft narratives according to patient data listings/statistical output and send draft narratives for peer-review
• Contribute to the validation process of medical translation of the documents.