Drug Safety Coordinator

• Perform oversight and/or processing for all types of safety events,  and other medically-related project information.
• Serve   as   pharmacovigilance    (PV)    lead    for   projects   providing   project    management/project management support as designated.
• Serve as support to management  in  all aspects of departmental  activities,  including  coordination of extra departmental tasks as needed
• Serve as technical  expert with regard to all aspects of  safety  monitoring,  per  global regulations,  (ieFDA,  ICH,  EMA)
• Ensure all ICON,  Sponsor,  and regulatory  timeframes  are met for the processing and reporting  of safety information
• Assist in  ensuring  the completion of all departmental  project activities  accurately in  accordance with ICON standards,  regulatory requirements,  and contractual obligations to Sponsors

• 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.
• Provide oversight  of and/or review and process  safety  events  (pre-marketing,  post-marketing,  device and  drug)   and/or   other   medically   related   information   per  assigned   tasks   and   project   specific procedures*
• Provide  input  and review  relevant  safety  tracking  systems  for  accuracy and quality  and  assist  with maintaining  project files
• Act as project manager for assigned projects,  liaising with sponsor,  and management  of timelines and budgets, as appropriate*
• Coordinate  and lead project teams as assigned
• Coordinate functional  safety activities  in support of project manager  on assigned projects
• Provide in-depth technical expertise*
•  Perform safety review of clinical and diagnostic  data as part of case processing
• Generation of project specific procedures*
• Support development  of post-marketing  safety activities,  such as PSMF, RMP and PBRER
• Support QPPV as required
• Support development  of clinical trial activities,  such as DSURs, 6-monthly  line  listings,  by liaising with other ICON departments  and/or other Sponsor vendors
• Liaise with investigational site, reporter, and/or Sponsor as necessary regarding safety issues such as safety systems support for line listings or other requests from Argus  or other safety database
• Liaise with ICON Medical Monitor,  project manager,  and other departments,  as appropriate*
• Actively identify out of scope activities and process efficiency/improvement needs
•  Review assigned contracts and coordinate  contract amendments/change orders as required*
• Coordinate  project team and Sponsor meetings  (including  Investigator meetings) and teleconferences as required

To  perform   this  job   successfully,   an  individual   must   be  able   to  perform   each   essential   duty satisfactorily. The requirements  listed below  are representative of the knowledge,  skill, and/or ability required.  Reasonable  accommodations  may be made to enable individuals with disabilities  to perform the essential functions.

•    A minimum of 3 year pharmacovigilance experience,  or other equivalent  clinical or pharmaceutical experience

•    Excellent  computer  skills  (Microsoft  Word,  Excel,  Outlook,  Access)  and  advanced  safety  database proficiency