Post: Senior Pharmacovigilance Reporting Associate
Job Description:
- Submission of Safety Reports: Responsible for submitting expedited Serious Adverse Event (SAE) reports, Periodic reports, line listings, and relevant safety information to various stakeholders including clients, Regulatory Authorities, Ethics Committees, investigators, third-party vendors, Partners, and ICON personnel within project specified timelines.
- Release of Safety Reporting Intelligence: Ensures timely release of safety reporting intelligence for expedited and periodic reports, line listings, to Regulatory Authorities, Ethics Committees, and investigators.
- Comprehensive Understanding: Maintains a comprehensive understanding of ICON’s safety reporting systems, processes, SOPs, WPs, guidance documents, and manuals associated with safety reporting.
- Oversight and Accountability: Provides oversight on assigned projects to meet ICON, Sponsor, and regulatory timeframes for reporting safety information or releasing global safety reporting intelligence requirements.
- Lead Capacity: Operates in a lead capacity ensuring ownership and accountability of safety reporting activities or safety reporting intelligence on assigned projects.
- Quality and Compliance: Assists in quality and compliance metric review, finance tracking, project resource tracking, client engagement, training oversight, and CAPA oversight as designated.
- Collaboration: Collaborates with project team members, client contacts, investigators, adverse event reporters, and third-party vendors as applicable, maintaining good relationships across functional units.
- Database Management: Works within multiple databases, ensuring timely updates and maintenance of project information or Pharmacovigilance intelligence information.
Additional Responsibilities:
- Document Filing and Quality Control: Performs filing and quality control of documents submitted to the eTMF or agreed filing solution ensuring file readiness on assigned projects for audits or inspections.
- Audit and Inspection Representation: Prepares for and represents the department in audits and inspections as designated.
- Coaching and Mentoring: Effectively coaches and mentors less experienced associates in all aspects of safety reporting or safety reporting intelligence and other work, as needed.
- Routine Project Activities: Implements and coordinates routine project activities, including presentations at client or investigator meetings, responses to client, authorities, and other stakeholders.
- Client and Internal Meetings: Participates in client and internal meetings, representing the Safety Reporting department for the assigned projects as designated.
- Therapeutic Area Understanding: Maintains understanding of applicable therapeutic areas and disease states as required.
- Travel: Expected to travel approximately 10% domestic and/or international, as required.
Additional Information:
- Location: Chennai, Trivandrum – India
- Industry Type: Pharma/ Healthcare/ Clinical research
- End Date: 30th May, 2024
This role offers an exciting opportunity to contribute to the advancement of clinical research and ensure compliance with regulatory standards in the pharmaceutical and healthcare industry. If you are a highly motivated individual with a passion for patient safety and a strong understanding of pharmacovigilance principles, we encourage you to apply.
