Drug Safety 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.

What you will be doing:

• ·       Manages collecting, processing, documenting, transmitting, Competent Authority (CA) declaring and following up of all Pharmacovigilance (PV) cases in marketed environment including: Spontaneous reports, literature report, post-marketing study, registries, CA cases, marketing research, etc. in China mainland.

  ·       Ensures accurate and consistent transcription, translations and data entry of all PV information for marketed products from source documents into local safety systems (LAM) with emphasis on timeliness and quality.

  ·       Maintain local tracking of PV case.

   

  ·       Performs monthly reconciliation with local other departments (e.g. medical information, anti-counterfeit, quality assurance, customer complaint centre and third party contractor, if applicable) for potential AEs resulting from medical inquiries and quality related complaints.

  ·       Performs monthly reconciliation with Centex TS to ensure all local AEs are accurately collected into safety database (ARGUS).

  ·       Participates in the PV trainings of local staff in contact with HCP.

  ·       Screens on a periodic basis of local literature.

  ·       Performs PV related activities according to pharmacovigilance agreement.

  ·       Tests and archive for local Business Continuity Plan.

  ·       Handles with PV 24 hours hotline notification.

  ·       Prepares and participates in audit or inspections, prepares CAPA if need.

You are:

• Pharmacovigilance Officer 1: 1-2 years of industry experience, preferably with 1+ year of PV related experience

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

ICON, including subsidiaries, 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, 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 or submit a request here.

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.