Senior Drug Safety & PV Specialist - Syneos Health - Bengaluru, India
(2016-10)
Overall 9.5 years of experience with Syneos Health as a Senior Drug Safety & PV Specialist.
- Responsible to create, update and quality control (QC) of xEVPRMs submitted to the European Medicines Agency (EMA) in line with requirements of Article 57(2)
- Validation of xEVPRM as per the reference document in EVWEB/Art57 database
- Medicinal product nullification, invalidation
- Ensure that XEVMPD relevant data for newly and maintenance of authorized medicinal products submitted within the specified timeline
- Responsible to review and solve the queries raised on 3rd acknowledgements by MAH's
- Have good understanding of different Acknowledgement levels and ACK codes
- Responsible to review the data and add IMPs/DMPs in EVWEB
- Manual recoding of terms for signal detection (MRT) for a healthy authority in Eudravigilance database
- Undertake information processing activities with extremely high reliability, high quality even in tight timelines according to SOP's
- Good knowledge on outlines on Article 57(2) of Regulation (EC) No 726/2004, EMA xEVMPD guidelines, Data quality control methodology, xEVMPD controlled vocabularies, Data Entry Tool (EVWEB) user manual, EMA registration process, MedDRA coding, EMA account management portal, Organisations management services (OMS) and SPOR master data
- Knowledge on ISO IDMP standards for the interpretation of entire product lifecycle: products in development, investigational products, products under evaluation and authorized products
- Have good understanding about ISO IDMP standards, EMA SPOR Data and IDMP requirements
- Participate in client meetings/investigator meetings/project specific training sessions
- Experience in compilation of Product Information (PI), Review of Module 2, Submission of applications via CESP, AW and labelling
- Perform quality checks on xEVPRM with reference to the source documents
- Review the errors for trends and consistency with the SLAs for various types of product codes
- Identify the root cause for errors and formulate CAPA (corrective and preventive action)
- Provide feedback to the individuals in form of trainings and the team on the results of the SLA quality checks and ensure implementation of CAPA for the errors identified
- Identify, support, on continuous improvement activities with Quality and Training Team
- Escalate issues or tasks outside the normal scope of work and to participate in audits or inspections
- Maintenance of KPI trackers and other relevant trackers required for the project at the SharePoint
- Management of Art. 57 service desk using the JIRA interface
- Triaging and directing the tickets received from Marketing Authorisation Holders to correct teams
- Responsible for managing those tickets by reviewing and correcting, as applicable, the ticket type, assigning labels, as well as prioritising the work according to the stablished SLAs
- Reviewing the tickets received from Marketing Authorisation Holders and answering to their queries within given specified timelines
- To mentor and guide the activities of drug safety associates
- Monitor trainings and compliance of associates in team
- Quality check of processed product records by the team and will extract the weekly & monthly quality reports
- Build a positive, collaborative team environment with team members
- Listen to the feedback of team members and develop strategies to achieve the targeted goals
- Participated in organization recruitment drives
- Received IWIN award and spotlight points (Applause award, for achieving highest quality, productivity, training and mentoring the team)
- Presented a session on Adverse Drug reactions (ADR) in Syneos
- Presented on the general topics like self-confidence and the current pandemic COVID-19
- Participated in the workshop on Pharmacovigilance and Clinical trials conducted by ACRI, Bangalore
