ICON Is A Leading Clinical Research Organisation (CRO) Committed To Advancing And Improving Patients’ Lives. With A Strong Focus On Collaboration, Partnership, Integrity, And Accountability, ICON Aims To Deliver Excellence In Drug Development And Become The Partner Of Choice For Its Clients.ICON plc is a global provider of drug development and commercialization services to pharmaceutical, biotechnology, medical device, and government organizations. Founded in 1990 and headquartered in Dublin, Ireland, ICON offers a range of services including clinical research, data management, laboratory testing, and consulting services. It operates in over 40 countries and has played a significant role in the development of numerous pharmaceutical products and medical innovations.Vacancy Details
- Position: Pharmacovigilance Assistant I
- Department: Pharmacovigilance
- Education: B.Pharm, M.Pharm, M.Sc, B.Sc, Pharm.D, Lifesciences
- Job Lcation : Chennai
- Experience : 0 Years / Freshers
- Salary : Rs. 28000
Responsibilities
- Receive And Distribute Incoming Safety Notifications To Appropriate Project Teams Or Sponsor Contacts.
- Maintain Data Entry For Serious Adverse Events (SAEs) And Miscellaneous Tracking Logs For All Current Projects.
- Prepare And Submit Courier Shipments And Electronic Safety Submissions On Behalf Of Project Teams.
- Manage Case Tracker And Support Distribution Of Safety-Related Documents.
- Upload Documents Into The Electronic Trial Master File (ETMF) And Track Status In Safety Tracking Tools.
- Perform Translation Management Process As Assigned.
- Organize Project Team And Client Meetings, Including Scheduling, Agendas, And Meeting Minutes.
- Support Project Manager With Financial Tasks, Purchase Orders, And Project Invoices.
- Maintain Project-Specific Email Distribution Lists And Training Compliance Tracking.
Adverse Event Reporting:
- Assisted in the collection, documentation, and analysis of adverse drug reactions (ADRs) and other safety-related events from various sources, including clinical trials and post-marketing surveillance.
- Ensured timely and accurate reporting of adverse events to regulatory authorities, maintaining compliance with industry regulations and guidelines.
Data Management and Analysis:
- Managed and updated pharmacovigilance databases to track and evaluate safety data, ensuring data integrity and completeness.
- Conducted preliminary data analysis to identify trends, signal detection, and potential safety issues, providing actionable insights to the team.
Regulatory Compliance:
- Supported the preparation and submission of safety reports and regulatory documents, ensuring adherence to FDA, EMA, and other regulatory requirements.
- Maintained knowledge of current pharmacovigilance regulations and guidelines to ensure compliance in all reporting and documentation activities.
Documentation and Record Keeping:
- Maintained detailed and accurate records of safety data, adverse events, and regulatory submissions, ensuring all documentation is up-to-date and easily accessible.
- Prepared and reviewed safety reports, summaries, and correspondence, contributing to high-quality and compliant documentation.
Collaboration and Communication:
- Coordinated with cross-functional teams, including clinical operations, medical affairs, and regulatory affairs, to ensure effective communication and resolution of safety issues.
- Provided support and training to team members and stakeholders on pharmacovigilance processes and procedures.
Process Improvement:
- Identified opportunities for improving pharmacovigilance processes and workflows, implementing changes to enhance efficiency and data quality.
- Contributed to the development and refinement of standard operating procedures (SOPs) and best practices for safety monitoring and reporting.
Training and Support:
- Assisted in training new staff and ensuring their understanding of pharmacovigilance practices, regulations, and systems.
- Provided support in resolving queries and issues related to pharmacovigilance processes and documentation.
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click here to apply now –Pharmacovigilance Assistant I job in India, Chennai | ICON (iconplc.com)