Graduate Pharmacovigilance Associate

As a Graduate Pharmacovigilance you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Review and process safety events (pre-marketing, post-marketing, medical device and drug) and/or other medically related information per assigned tasks and project specific procedures
• Perform review of abstracts and full articles to identify safety information from literature source for both pre and post marketed products.
• Participate in the generation of data listings from the safety database and assumes responsibility for accuracy of the data.
• Complete adverse event follow-up in writing and/or by phone based on requirements for each Client.
• 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 as part of case processing.
• Liaise with investigational site, reporter, and/or Sponsor as necessary regarding safety issues.
• Attend project team meetings and teleconferences as required.
• Perform other activities as identified and requested by management, including but not limited to:
  Respond and process medical information inquiries, including inquiries related to adverse events and product complaints for Clients’ product(s), as per their agreement with ICON.
  Receives inquiries via phone, fax or email from consumers or healthcare professionals in support of marketed products; triages the inquiry as a request for medical information, product quality compliant and/or adverse event and processes received information in accordance with project specific instructions.
  Follows up on cases as appropriate.
  For ICON Strategic Solutions, may also include:
  •Submission of expedited Serious Adverse Event (SAE) reports, Periodic reports, line listings and applicable safety information to clients, Regulatory Authorities, Ethics Committees, investigators, third party vendors, Partners, and ICON personnel, if required & as agreed with client during study set-up, within study specified timelines.
• Develop understanding of ICON's safety reporting systems, processes, and conventions, as appropriate.
• Develop understanding of ICON Standard Operating Procedures (SOPs), Working Procedures (WPs), guidance documents and manuals associated with safety reporting.
• Support filing activities in the eTMF ensuring file readiness on assigned projects for audits or inspections.•Serve as safety reporting or quality complaint processor for assigned projects, providing support as designated.
• Complete adverse event and/or product quality complaint cases follow up in writing and/or by phone based on requirements for each Client.

You are:

• Bachelor’s degree in a health, life sciences or other relevant field of study.
• The successful candidate will have relevant pharmaceutical industry experience, preferably in pharmacovigilance/drug safety, with knowledge of medical terminology and coding systems.
• All employees must read, write and speak fluent English and host country language.

What ICON can offer you:

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

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.