Senior Drug Safety Associate

Senior Drug Safety Associate

Location: Warsaw, Poland

ICON Plc, a leading global Contract Research Organisation (NASDAQ listed) employing 13,500 people in 37 countries, is looking to hire a Senior Drug Safety Associate to join the team in our Warsaw offices.

The Role:

• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
• 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.
• Travel (approximately 10%) domestic and/or international. Complete all departmental project activities accurately in accordance with ICON SOPs, Project Specific Procedures, regulatory requirements, and Sponsors processes.
• Prepare and perform quality check of regulatory documentation packets, and coordinate the timely completion and submission of required reports to Health Authorities, Ethic Committees, Principal Investigators and third parties.
• Ensure compliance with regulatory reporting requirements for safety reporting (pre-marketing, post-marketing, device and drug) and/or other medically related information per assigned tasks and project specific procedures.
• Ensure all ICON, Sponsor, and regulatory timeframes are met for the reporting of safety information.
• Ensure the completion of all departmental project activities accurately in accordance with ICON standards, regulatory requirements, and contractual obligations to sponsors.
• Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files. Liaise with Sponsors, ICON project managers, investigational sites, Competent Authorities, local notified bodies and third parties as necessary
• Attend project team meetings and teleconferences as required.
• Maintain the projects regulatory submission files are in inspection ready state at all times. Prepares for, and attends audits and inspections.
• Facilitate and respond to company, client and regulatory audits where required.
• Delivers presentations to internal and external customers as required.
• Holds the training for GRA project team, Investigators and other departments on regulatory reporting activities. Generation of project specific procedures.
• Act as safety reporting lead for multiple projects providing management/project management support.
• Actively identify out of scope activities.
• Train/mentor Drug Safety Associate staff.
• Participate in interdepartmental activities and assist management with weekly and monthly project status reports including quality review findings and metrics.
• Alert Line Manager to any quality or timeline issues.
• Shares of ideas and suggestions with team members ensuring effective communication.
• Perform other activities as identified and requested by management

Role Requirements:

• The successful candidate will have relevant clinical research/pharmaceutical industry experience, preferably in pharmacovigilance/drug safety, with knowledge of medical terminology and coding systems.
• Must be fluent in written and verbal English with good communication skills and basic computer skills.  Detail orientated and capable of working effectively within a team environment.
• Medical/science background and/or bachelor’s degree or local equivalent.

Benefits of Working in ICON

ICON enjoys a strong reputation for quality and is focused on staff development.  We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career. 

We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart.   Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. 

This varies from country to country so a dedicated recruiter will discuss this with you at interview stage. We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.