Divya Goswami

• Responsible for ICSR management and submission to applicable regulatory authority.
• Responsible for preparation, review and implementation of standard operating procedure/ work instructions.
• To assist in preparation of CAPA, Deviation, Change control and Root cause analyses
• Responsible for global and local literature surveillance.
• Responsible for effective compliance of ICSR systems.
• Responsible for coordinating with responsible departments on an urgent basis related to Pharmacovigilance activities and queries.
• To provide the expert comments in process of reference safety information updates.
• To assist internal and external audit/inspections.
• To evaluate potential medically relevant information with market complaints
• To do the monthly reconciliation with plant QA departments
• To handle calls for Adverse event (AEs), Product quality complaints (PQCs), Medical inquiries (MIs) and preparing source documents for the same.
• To act as training coordinator and facilitate Inter-department communication with CQA

• Pull listing and Perform investigations of late Individual Case Safety Reports (ICSRs) to Health Authorities (HA) and late distribution to Business partners (BP)
• Initiate initial investigation to identify lateness reason and responsible organization, follow up with responsible organization to request lateness reason and CAPA
• Validate the information upon receipt of lateness reason and CAPA, follow up as needed and enter the data in compliance tool
• Perform Quality check on the data fields in the PSR compliance dashboard to check the data completeness and follow up with responsible organization to resolve discrepancy upon identification of missing or inconsistent data
• Perform reconciliation activities to verify accuracy of the data configurations in client tools
• Adhering to compliance procedures and internal/operational risk controls in accordance with any and all applicable regulatory standards, requirements and policies
• Communicate and interact effectively within and across all Client key stakeholders and within internal team management as appropriate
• To attend all the Internal Trainings and Client Trainings and ensure compliance with applicable guidelines
• Responsible for all content milestone deliverables viz- quality and accuracy, timeliness, and efforts
• Be aware of all organizational, divisional, and client-related policies and procedures related to quality, information security and data privacy
• Responsible to strictly adhere to quality standards for various deliverables as decided by the business unit or client
• Responsible to maintain confidentiality and copyright rules for various deliverables/clients and company norms
• Follow all the security rules with regard to various standards like ISMS, ISO, CMMI and client guidelines
• Responsible to participate in assigned training programmes relevant to the job
• Responsible to build mastery in assigned deliverables through self-learning and formal trainings
• Learn to review content for the respective deliverables as assignee
• Daily monitoring of emails for Adverse events and technical product complaints
• Initial triage and data entry in the database for adverse event (AE)

• Experienced in management of Individual Case Safety Reports (ICSRs) of all case types (spontaneous, clinical studies and solicited programs) which includes: Triage of ICSRs to determine whether they qualify for expedited reporting or not and the timelines within which they need to be submitted to the regulatory authorities
• Data entry of ICSRs in the safety database
• Medical review of ICSRs including determining the expectedness of adverse events against various labeling documents (such as SPC, CDS, IB etc.), writing case summaries, assessing causalities if required and writing company comment if required
• Experienced in MedDRA coding in accordance with 'MedDRA Term Selection: Points to Consider'
• Maintaining a good knowledge of the safety profile of assigned drugs, Reference Safety Information documents, data entry conventions and guidelines, clients' procedures and international drug safety regulations including: ICH guidelines on safety and efficacy, CIOMS, New EU PV legislation/GVP Modules
• Experienced in handling the ERP (Enterprise Resource Planning) system
• Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
• Responding to clients/customers in a timely manner
• Forward follow-ups with no new medically significant information to distribution
• Maintain expertise and knowledge of all assigned products within a therapeutic area, applicable corporate and global regulations, guidelines, Standard Operating Procedures, writing practices and search functions in the safety database
• Promote/participate, as appropriate, in internal and external safety activities.