Pharmacovigilance Assistant I

7 months ago

Chennai Tamil Nadu, India Icon plc Full time

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.

If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

Business Support:

- Initiates appropriate actions to protect data privacy with regards to received unrequested personal identifiers.
- Maintains data entry for SAEs and miscellaneous tracking logs for all current projects.
- Prepares and submits courier shipments and electronic safety submissions on behalf of the project teams, including acknowledgement uploads to Safety Reporting System and maintenance of address data for safety submissions.
- Case tracker management and support
- Distribution of safety related documents like Clinical Trial Application (CTA), Power of Attorney (PoA) or delegation documents, and website searches as support to the safety reporting intelligence team.
- Uploads documents into the electronic Trial Master File (eTMF) and tracks the status in the Safety Tracking Tools.
- Downloads Safety Reporting Post-Marketing ICSR.
- Completes EudraVigilance acknowledgement of receipt (AoR) tracking in Safety Reporting System.
- Safety Reporting (CA Country Portal submissions, Monitoring of mailboxes and/or Client Portal, Support for expedited and periodic reporting and Bulk report submission and reconciliation)
- Performs the Translation Management Process as assigned.
- Maintain departmental and global calendars as required.
- Completion of monthly metrics.
- Perform offsite archiving activities as required.
- Applies knowledge and adheres to company policies and procedures including corporate guidelines and best practices. Flag errors/non-conformance to established processes.
- Identifies and recognizes problems that have established precedents and limited impact. Refers non-standard questions and problems to higher levels.

Project Management Support:

- Organizes project team and client meetings including scheduling, agendas, preparation of presentations and meeting minutes.
- Organizes, reviews and manages project specific information and material following applicable company processes, (such as organizational charts, Project Management Plans, project status reports).
- Supports the Project Manager with financial tasks. Support and processes purchase orders and project invoices.
- Uploads and files all documents within allotted timeframe into the electronic Trial Master File (eTMF) or Trial Master File (TMF), including package preparation, reconciliation of the TMF and the safety tracking tools for inspection readiness, sampling and coherence QC and query resolution and follow up. Monitoring and filing of project specific mailboxes.
- Maintains training matrix, including assigning and tracking project specific trainings and tracks training compliance as applicable in the relevant system(s).
- Maintenance, coordination and access of project Enterprise Document and Content Management Systems (EDCMS) and mapped drives etc.
- Monitors project team’s approved Curriculum Vitae (CV) dates in eTMF or Project File for compliance with applicable SOP.
- Updates project metrics and team members in applicable systems.
- Perform other activities as identified and requested by management.

Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.

We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.

But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex

  • Pharmacovigilance Assistant I

    2 months ago

    Chennai, Tamil Nadu, India ICON Plc Full time

    Pharmacovigilance Assistant I ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development - Initiates appropriate actions to protect data privacy with regards...

  • Pharmacovigilance Assistant I

    1 month ago

    Chennai, Tamil Nadu, India ICON Plc Full time

    Pharmacovigilance Assistant I ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development - Initiates appropriate actions to protect data privacy with regards...

  • Pharmacovigilance Associate

    2 months ago

    Chennai, Tamil Nadu, India Icon plc Full time

    Pharmacovigilance Associate ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development - Review and process safety events (pre-marketing, post-marketing,...

  • Pharmacovigilance Associate

    2 months ago

    Chennai, Tamil Nadu, India ICON Plc Full time

    Pharmacovigilance Associate ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development - Review and process safety events (pre-marketing, post-marketing,...

  • Pharmacovigilance Associate

    4 months ago

    Chennai, Tamil Nadu, India Icon plc Full time

    Pharmacovigilance Associate - India, Chennai Hybrid: Office/Remote ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development What ICON can offer you: -...

  • Pharmacovigilance Associate

    7 months ago

    Chennai, Tamil Nadu, India ICON plc Full time

    At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...

  • Pharmacovigilance Reporting Associate

    2 months ago

    Chennai, Tamil Nadu, India ICON Plc Full time

    Pharmacovigilance Reporting Associate - India, Chennai Hybrid: Office/Remote ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development INSERT ADVERT TEXT...

  • Pharmacovigilance Reporting Associate

    2 weeks ago

    Chennai, Tamil Nadu, India ICON Plc Full time

    Pharmacovigilance Reporting Associate ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development - Submission of expedited Serious Adverse Event (SAE)...

  • Pharmacovigilance Reporting Associate

    3 weeks ago

    Chennai, Tamil Nadu, India ICON Plc Full time

    Pharmacovigilance Reporting Associate ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development **Job Description**: - Submission of expedited Serious...

  • Commi I

    6 months ago

    Thoraipakkam, Chennai, Tamil Nadu, India Pearltri Foods Pvt Ltd Full time

    **Commi I- Job Description** **Good Knowledge for Indian Kitchen** **Education**: - A high school education or diploma in culinary is required. Basic computer skills and familiarity with inventory systems. **Experience**: - Previous **Hospitality** and **Catering** industry experience working at a Commis I Chef level in a good-quality restaurant - One...

  • Designer (C&i)

    3 months ago

    Chennai, Tamil Nadu, India Cadd Centre Full time

    **Position**: Designer (C&I) **Location**:Chennai **Experience**:2 - 5 years in preparation of Hook -Up Diagrams, Logics, Loop Schematics, P&IDs, Cable tray layouts, Routing diagrams. **Mandatory Skills**: Familiarization with AutoCAD, Microsoft Office. **Responsibilities**:Preparation of instrumentation drawings for power plant equipment. For any...

  • Quality Assurance Technician I, Vega Support

    3 months ago

    Chennai, Tamil Nadu, India ADCI - Tamil Nadu Full time

    BE, BTech, Master of computer Applications (MCA), Bsc Computers, BCA, MSc Information Technology (IT) QAT I will primarily function in teams within QS that have opportunities to write and maintain test cases for different features. They exhibit technical capability to execute automated test scripts, develop utilities or tools to improve efficiency and...

  • Quality Assurance Technician I, Fire Tv

    2 weeks ago

    Chennai, Tamil Nadu, India ADCI - Tamil Nadu Full time

    1+ years of Games Industry (supporting title Development, Release, or Live Ops) experience QAT I will primarily function in teams within QS that have opportunities to write and maintain test cases for different features. They exhibit technical capability to build and execute automated test scripts as necessary, develop utilities or tools to improve...

  • Clinical Nurse Reviewer I

    2 months ago

    Chennai, Tamil Nadu, India ICON Plc Full time

    Clinical Nurse Reviewer I- Home based - Chennai/ Bangalore ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Clinical...

  • Associate, Reconciliation Representative I

    2 months ago

    Chennai, Tamil Nadu, India BNY Mellon Full time

    Overview Associate, Reconciliation Representative I At BNY, our culture empowers you to grow and succeed. As a leading global financial services company at the center of the world’s financial system we touch nearly 20% of the world’s investible assets. Every day around the globe, our 50,000+ employees bring the power of their perspective to the table to...

  • myGwork | Quality Assurance Technician I, Vega support

    2 weeks ago

    tamil nadu, India myGwork Full time

    This job is with Amazon, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.DESCRIPTION:QAT I will primarily function in teams within QS that have opportunities to write and maintain test cases for different features. They exhibit technical...

  • Quality Assurance Auditor I

    1 month ago

    Chennai, Tamil Nadu, India ICON Plc Full time

    Quality Assurance Auditor I - Chennai/Bangalore - Remote or Hybrid working ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development - We are currently...

  • myGwork | Quality Assurance Technician I, Fire TV

    2 weeks ago

    tamil nadu, India myGwork Full time

    This job is with Amazon, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.DESCRIPTION:QAT I will primarily function in teams within QS that have opportunities to write and maintain test cases for different features. They exhibit technical...

  • Rep I

    7 months ago

    Chennai, Tamil Nadu, India TransUnion Full time

    TransUnion's Job Applicant Privacy Notice **What We'll Bring**: Rep I with GCC Chennai **What You'll Bring**: - Experience as a highly efficient voice contact center agent in an inbound call center is preferable (Previous Chat experience - Advantageous), that will professionally manage all consumer’s interactions as rostered within required parameters...

  • Associate, Fund Administration I

    4 weeks ago

    Chennai, Tamil Nadu, India BNY Mellon Full time

    Overview Associate, Fund Administration I At BNY, our culture empowers you to grow and succeed. As a leading global financial services company at the center of the world’s financial system we touch nearly 20% of the world’s investible assets. Every day around the globe, our 50,000+ employees bring the power of their perspective to the table to create...