• Job Description

  Req#: JR129795
  Pharmacovigilance Reporting Associate - Warsaw - Sofia - Office or Home

  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

  We are currently seeking a Pharmacovigilance Reporting Associate to join our diverse and dynamic team. As a Pharmacovigilance Reporting Associate at ICON, you will be responsible for the accurate and timely preparation of safety reports related to clinical trials and post-marketing activities. You will ensure compliance with regulatory requirements and contribute to the effective management of safety data to support patient safety and regulatory compliance.

  Job Des c rip tion Summary:

  • S e rve as s af e ty r epo r ting intellig e n ce pr o ce ssor and may lead s afe ty r e por t ing inte l lig ence s t a n d- alone p rojects, p rovidi ng manageme nt s u pport as designat e d.

  • Rec o gnize, e xemplif y, and a d h ere to ICON's valu e s, which ce n tre ar ound our c ommitment to Peop l e, Clie n ts, a nd P erf ormanc e.

  • As a member of staff, the employee is e x p ected to embrace a nd c o n tribute to our cultu re of p r o ce ss im p rov eme nt with a foc us on s t reamlini ng our p roces s es adding v a lue to our busi n e ss a nd mee ting clie nt nee d s.

  • Com ple te all d epartme ntal a ctivi ties a c cur ately in acco r dance with ICON SOP s, regulatory re q uirements, a nd c lie nt pr o ce s ses as a ppli cable.

  • Responsi ble for safety r e porting i n t elli gence ac t i vities on assi gned ac t i v i tie s, w orking in a cus t omer f o cus ed a p p r oa ch and an audit a nd i n s p ec tion re a dy minds e t.

  • Demon s t r a te a q uality mi n d set s u pporting c o m plianc e.

  Job Des c rip tion:

  • Maintain s afe ty r e p orting r e q uireme n ts f or e x p edited and periodic r eports, line lis t ings, for Regulatory Authoritie s, E t hics C ommit tee s, and inv e s tig ators wit hin sp ecified time l i n es as well as other Pharmac o v igilance inte llig ence as p er assignment and in a cc o r d a n ce with c ompany p r o ce d u re s.

  • Maintain a strong un d e r s t and ing of ICON's P harm a c o v igilance inte llig ence systems, p r o ces ses, and c o nventio n s, as a p pli c abl e.

  • Maintain a strong un d e r s t and ing of ICON Stan d a rd Ope r ating P rocedu res ( SOPs), W orking P r o ce d u res (WPs), guidance do cume n ts and ma n u als as s o ciated wi th P h a rmacovigilance in t e l lig enc e.

  • P erf orm ov ersight of as sign ed pr ojects e n s uring all ICON, Spon s o r, and regulatory time f rames a re met for t he mai n tenance of r e l a ted gl obal s afe ty r epo r ting inte llig e n ce r e q uir eme n t s.

  • Ope r ate in a lead capac ity e n s uri ng ow n e r s hip and accou n tability of safety r e p ort i ng in t e l lig ence on a ssign ed p roj ects.

  • Ensure comple t ion of all assign ed p roject activi ties accur a tely a nd in accor dance with ICON

  s t and a rds, r egulatory re quirements, and client c o n t r a c t ual o bli g a t ions.

  • Colla bo r ate with various p a rties s u ch as pr oject t eam members a nd clie nt c ontac ts as ap plica b l e. Build a nd ma i n t ain good rela t ions hips ac ross fu n cti o nal u nits.

  • Work wit hin mul t iple da t a base s. Main tena n ce of P harmac ovigilance i n t e l ligence inf orma t i on with time ly updates to the i n tellig e n ce databas e s.

  • P rep a re f or and re p rese nt the de p artment in au d i ts a nd ins p ec tio ns as design ated.

  • Review r egulatory and safety r epor ting i n t elli gence to k eep up d ated on cur r e nt r egulations, p ractice s, proce dur e s, and p rop o sals as assig n e d.

  • C o a ch and men t or le ss e x p erienced associates in s afety re p o rting i nte l lig e nce ac tivi ties and o ther work, as per assignment.

  • Par ticipa te in client and internal mee tin g s, rep re s e n ting the Saf e ty Rep ort ing d e p a r tme nt for the assig n ed p r o jects, as d esign ated.

  • T r avel ( a p p r o ximately 10%) d ome stic an d / or i n ter n a tio nal, as r equired.

  • P erf orm o t h er a c tiv i ties as i d e nti fi ed and re ques t ed by ma n a g eme nt

  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 maximize 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 site to read more about the benefits ICON offers.

  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, color, 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.

  Are you a current ICON Employee? Please click here to apply

• About the company

  ICON is an Irish-headquartered developer of drugs to the pharmaceutical, biotechnology and medical device industries.

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