Projekt‐ & Berufserfahrung
1/2021 – offenTätigkeitsbeschreibung
-Responsible for writing Clinical Evaluation Plans, Clinical Evaluation Reports, Creation of SSR reports.
-Ensures the CER and SSR files are linked to appropriate Quality Systems and Regulatory documents
-Support and act as SME during audits and inspections
-Actively partner with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs.
12/2019 – 12/2020Tätigkeitsbeschreibung
- Initiate and manage the Pharmacovigilance activity of the Company encompassing all the plants
- Liaison with European and African development agencies, for technical support and to create visibility for Africure
- Manage Medical Affairs activities
Medical Writing, Pharmazie
1/2019 – 12/2019Tätigkeitsbeschreibung
-Lead projects involving Clinical Evaluation Reports, PSURs, RMP, PMS plans.
-Literature Database (PubMed, Embase, Ovid) & Regulatory Database Search (MHRA, Swissmedic, BfArM, FDA MAUDE, FDA Recall) handling
1/2018 – 12/2018Tätigkeitsbeschreibung
Lead projects to enhance the methodologies and processes used to monitor and improve safety case and aggregate report quality and compliance. Lead the preparation and maintenance of manuals and other documents related to quality and compliance monitoring. Ensure safety cases and aggregate reports meet global Health Authority requirements and Company quality standards.
Contribute to projects aimed at optimizing methodologies and processes to monitor safety cases and aggregate reports compliance and quality. Ensure compliance to
i) safety information exchange commitments in Pharmacovigilance Agreements with global license partners
ii) Health Authority submission requirements (ICSRs and aggregate reports) and
iii) Novartis internal timelines for safety case databasing and aggregate report production through:
•Compiling and analyzing compliance data
•Leading the investigation in to the root cause(s) for late transfers/late submissions
•Performing trend analyses of the results of the root cause analysis
•Collaborating with process owners and other SMEs to develop and implement CAPAs and, post implementation, verify the effectiveness of these.
•Communicating/escalating compliance issues to the Pharmacovigilance Compliance and Quality Management and Patient Safety Alliance teams
•Preparing reports / presentations on compliance for CMO&PS management
Perform reconciliation of safety information exchanged with global license partners to confirm completeness, investigation in to any gaps identified and completion of remedial actions.
9/2016 – 1/2018Tätigkeitsbeschreibung
1. Evaluation and Quality Review of Serious Adverse Event / Post Marketing Adverse Event to ensure accurate and consistent data entry and processing from source documents, with emphasis on accuracy, timeliness and quality.2. Assess adverse event reports for seriousness, causality and expectedness as per the Investigator Brochure/Basic Prescribing Information/US package insert, collaborating with Medical Safety Expert.3. Determine the necessity for follow-up and prepare follow-up requests and targeted check-lists.4. Drive process changes according to internal and external drivers.5. Act as Subject Matter Expert during audits & inspections and develop Corrective and Preventive Actions and measure effectiveness. Support QA in creating and handling of deviations and exception requests. 6. Develop, monitor process related metrics and timely release of monitoring reports. 7. Support in creating and maintaining the PSMF.Eingesetzte Qualifikationen
Pharmaforschung, Windows 7, MS Office (Anwenderkenntnisse)
1/2012 – 3/2014Tätigkeitsbeschreibung
Facilitates safety monitoring by optimizing scientific quality documentation and data entry of Safety case reports for Company drugs.
• Ensure scientific rigor through accurate, complete and consistent data entry of adverse event reports from source documents with emphasis on timelines and quality.
• Assist with related administrative and procedural activities, training and mentoring other Safety Processing associates.
• Support Safety Projects or database validation activities as required.
• Support writing activities- aggregate reports, standard operating procedures, process related documents and product guidance documents.
Ort: Ranchi, India
Ort: Hyderabad, India