Job title: Drug Safety Manager
Job description: Description
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.
As a Senior Drug Safety Associate at ICON, you’ll work within a large-scale, fast-paced environment. As part of our Safety Reporting Group in ICON, our DSA’s contribute to our culture of process improvement, perform expedited and periodic safety reporting, maintain projects and liaise with Sponsors, ICON project managers and investigational sites as required. We pride ourselves on our amazing company culture, where we work as one team to achieve industry-leading results.
*As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes, adding value to our business, and meeting client needs.
- *Complete all departmental project activities accurately and in accordance with ICON SOPs, Project Specific Procedures, regulatory requirements, and Sponsors’ processes
- *Serve as technical expert with regard to all aspects of pharmacovigilance, per global regulations, (ie FDA, ICH, EMA). Ensuring all ICON, Sponsor, and regulatory timeframes are met for the processing and reporting of safety information
- * Consistently contributes to solving technical and/or operational problems by proposing and executing innovative solutions, which influence program/project direction.
- *Coordinate and present at meetings (project and department) as required.
- *Train/mentor other team members
- *Prepare and participate in internal and external audits, and in regulatory inspections.
- Management of assigned teams to ensure project and departmental deliverables are met.
- Serve as the main point of contact for the Client/Sponsor/Customer for the life cycle of assigned stand-alone projects and full-service projects.
- Develop and maintain excellent client relationships, including at the portfolio level.
- Oversee implementation of projects, including client communications, project-specific plans, system set-up, and establishment of appropriate and agreed-upon metrics.
- Completion of project status reports/review meetings, including burn hours, profit margins, quality review findings, and other metrics.
- Provide leadership and oversight to the team that is processing Safety Events (Clinical pre marketing, post-marketing, device and drug and/or other medically related information per assigned project specific procedures
- Lead identification of out-of-scope activities and process efficiency/improvement needs or implement contract amendments/change orders as required.
- Provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner.
- Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files
- Participate in Business Development activities as requested.
- Support QPPV as required.
- Responsible for preparation and execution of risk management activities and project mitigation plans as needed, in collaboration with other team members.
- Assist in ensuring the completion of all departmental project activities accurately in accordance with ICON standards, regulatory requirements, and contractual obligations to Sponsors
- Perform other activities as identified and requested by management.
- Travel (approximately 10%) domestic and/or international.
Safety Technology Lead specific:
- Provide in-depth technical expertise of a Safety Database or Safety tracking system.
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, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
Location: Thiruvananthapuram, Kerala
Job date: Sun, 22 May 2022 07:03:36 GMT
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