Drug Safety Associate
Icon plcShanghaiUpdate time: September 3,2019
Job Description
Are you passionate about serving as the safety reporting lead? The DSA will prepare, perform quality checks of, and submit expedited and periodic reports for all types of safety events and other medically-related project information under mentorship of a Drug Safety Coordinator.
Senior Drug Safety Associate role within ICON:
The Senior Drug Safety Associate prepares and performs quality checks of regulatory documentation packets and coordinates the timely completion and submission of required reports to Health Authorities, Ethic Committees, Principal Investigators and third parties. You will also 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.
- Recognize, exemplify and enforce to ICON's values which centers around our dedication 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 (up to approximately 15%) domestic and/or international as applicable
- Complete all departmental project activities accurately in accordance with ICON SOPs, Study Specific Procedures, regulatory requirements, and Sponsors processes
- Review and process serious adverse events, spontaneously reported adverse reactions and/or other medically related information per assigned tasks and study specific procedures
- Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files
- Perform safety review of clinical and diagnostic data
- Liaise with investigational site, reporter, and/or Sponsor as necessary regarding safety issues
- Attend project team meetings and teleconferences as required
- Serve a resource for investigational sites and ICON personnel on safety-related issues
- Liaise with Sponsor and attend Sponsor meetings, as required
- Liaise with ICON project manager, and other groups , as appropriate
- Identify out of scope activities in conjunction with the MSS Functional Lead and/or Clinical Project Manager
- Train/mentor newly hired DSA staff, as requested
- Assist with coordination of interdepartmental activities (e.g. listing review, quality control, quality assurance (audits), miscellaneous project activities)
- Generate study specific procedures for contracted departmental services
- Assist management with weekly and monthly project status reports
- Assist with generation of regulatory reports as necessary to ensure regulatory compliance .
- Conduct safety presentations for start-up meetings, Investigator meetings and other meetings
- Serve as lead DSA on all (including global) medical or safety projects as assigned
- Assist the MSS Functional Lead (e.g. Medical Monitor) independently
- Perform other activities as identified and requested by management
To succeed you will need:
We are seeking candidates with a medical/science background with a bachelor’s degree. Minimum of 3-4 years related experience in Pharmacovigilance. To be successful you will be expected to be proficient in Microsoft Office skills (Word, Excel, and Access). Have good communication skills, be fluent in written and verbal English, detail-oriented and have the ability to work effectively within a team environment.
Benefits of working at ICON:
In addition to partnering with the top pharmaceutical and biotech companies in the world we offer a strong benefits package that includes a comprehensive health plan, retirement plans, competitive pay, bonus plans, vacation, and other incentives.
ICON has a strong reputation in our approaches to clinical development. We apply scientific and operational perfection across all phases of clinical trial outsourcing services for our clients. We work with top pharmaceutical organizations on emerging therapeutic areas which include but are not limited to Oncology, Vaccines, CNS, Cardiovascular and Pain. We are presently in over 40 countries with over 80 offices worldwide and over 10K employees globally.
We invite you to review our opportunities at www.iconplc.com/careers.
What’s Next?
Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.
ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.
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