Associé Bilingue de la Pharmacovigilance / Bilingual Drug Safety Associate
Associé Bilingue de la Pharmacovigilance / Bilingual Drug Safety Associate
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Job Description
Our team members are at the heart of everything we do. At Cencora we are united in our responsibility to create healthier futures and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!
Job Details
Principales Fonctions et Responsabilites:
- Recevoir numriser et documenter tous les renseignements cliniques pertinents en conformit avec la PON/protocoles et les lois applicables;
- Travailler directement avec les clients internes et externes pour demander des renseignements additionnels ou des prcisions selon les besoins;
- Examen des documents de donnes sources (y compris lexamen des rapports de visite RPP/PIR) et triage des informations sur les vnements indsirables et des plaintes sur la qualit des produits en fonction des besoins des clients;
- Saisie des donnes et saisie des informations sur les vnements indsirables et des plaintes relatives la qualit des produits dans les bases de donnes spcifiques au programme;
- Tri et classement des documents entrants;
- Effectuer un contrle de la qualit des rapports dvnements indsirables conformment aux instructions de travail;
- Assister ou effectuer les tches de vrification des donnes sources;
- Examiner la littrature mdicale et scientifique pour trouver des informations sur linnocuit;
- Prparation des rapports de rapprochement (hebdomadaires mensuels etc.);
- Activits de transcription de traduction et de rdaction;
- Prparation et ralisation de lettres de suivi sollicites et de clarifications de donnes;
- Assister et participer au processus de nonconformit/ACAP.
- Lassoci de la pharmacovigilance se verra galement confier dautres fonctions et tches au besoin de temps autre.
- Dans le cadre de ce poste il peut tre ncessaire de travailler sur demande ou tre en disponibilit.
Experience et Scolarite Requises:
- Niveau dtudes collgiales minimum requis; Un diplme ou un diplme avec une concentration en sciences de la vie est un atout important;
- 1 3ans dexprience dans le domaine de linformation mdicale de la recherche clinique ou de linnocuit des mdicaments ou une exprience quivalente et connexe en pharmacie ou dans le domaine pharmaceutique
- Connaissance de lindustrie de la pharmacovigilance y compris une connaissance jour des directives de pharmacovigilance de Sant Canada de la FDA de la EMEA et de lICH;
- Capacit dadaptation au changement et volont dacqurir de nouvelles comptences au besoin;
- Une exprience dans le domaine mdical ou pharmaceutique est un atout;
- Le bilinguisme (anglais/franais) est un atout;
- Capacit de travailler un quart de travail de 8heures entre 8h et 20h le cas chant.
Competence Minimales Connaissances et Aptitudes Requises:
- De solides aptitudes danalyses;
- Capacit de communiquer efficacement oralement et par crit;
- Comptences interpersonnelles efficaces;
- Sens de lorganisation; capacit effectuer plusieurs tches la fois;
- Un souci du dtail suprieur et dmontr;
- Capacit respecter les chances de faon systmatique;
- Excellentes aptitudes en rsolution de problmes; facilit de communication et capacit rsoudre les problmes de faon efficace et efficiente;
- Connaissances informatiques (incluant: Microsoft Word Excel PowerPoint et dautres programmes Office);
- Un bon accs lInternet est ncessaire pour le tltravail.
Primary Duties and Responsibilities:
- Receive scan and document all pertinent clinical information in compliance with SOP/protocol and applicable legislation
- Work directly with internal and external clients to request additional information or clarification as necessary;
- Review of source data documents (includes visit report/PIR review) and triaging adverse event information and product quality complaints as per client needs;
- Data entry and submission of adverse event information and product quality complaints into program specific databases;
- Sorting and filing of incoming documents;
- Perform quality check on adverse event reports as directed by the work instructions
- Assist with and/or perform source data verification checks
- Screening medical and scientific literature for safety information
- Preparation of Reconciliation (weekly monthly etc.) Reports
- Transcription translations and redaction activities
- Preparation and conducting solicited followup letters and data clarifications
- Assist and participate in the nonconformance/CAPA process
- The Drug Safety Associate will also be assigned other duties and tasks as required from time to time
- May be required to be on standby/on call as part of this role
Experience and Educational Requirements:
- Minimum college level education required. A diploma or degree with a concentration in Life Sciences is a strong asset;
- 13 years experience in Medical Information Clinical Research or Drug Safety or equivalent and related experience in pharmacy or pharmaceutical fields;
- Knowledge of Pharmacovigilance industry including up to date knowledge of; pharmacovigilance guidelines of Health Canada US FDA EMEA and ICH;
- Adaptability to change and to learn new skills as required;
- Experience in the medical and/or pharmaceutical field(s) medical terminology is an asset;
- Bilingual English/French required
- Able to work any 8hour shift between 8:00 AM8 PM if necessary
Minimum Skills Knowledge and Ability Requirements:
- Strong analytical skills
- Ability to communicate effectively both orally and in writing
- Effective interpersonal skills
- Effective organizational skills; ability to multitask
- Superior proven attention to detail
- Ability to consistently meet deadlines
- Excellent problemsolving skills; ability to communicate and/or resolve issues effectively and efficiently
- Computer skills (including knowledge of Microsoft Word Excel PowerPoint and other Office Programs)
- Good internet required for remote work
The successful candidate will (requirement)/may (asset) have daily contacts with unilingual Englishspeaking customers patients or peers from crossfunctional teams.
Le candidat retenu aura/pourrait avoir des contacts quotidiens avec des clients des patients ou des pairs unilingues anglophones dquipes interfonctionnelles.
What Cencora offers
We provide compensation benefits and resources that enable a highly inclusive culture and support our team members ability to live with purpose every day. In addition to traditional offerings like medical dental and vision care we also provide a comprehensive suite of benefits that focus on the physical emotional financial and social aspects of wellness. This encompasses support for working families which may include backup dependent care adoption assistance infertility coverage family building support behavioral health solutions paid parental leave and paid caregiver leave. To encourage your personal growth we also offer a variety of training programs professional development resources and opportunities to participate in mentorship programs employee resource groups volunteer activities and much more.
Full time.
Equal Employment Opportunity
Cencora is committed to providing equal employment opportunity without regard to race color religion sex sexual orientation gender identity genetic information national origin age disability veteran status or membership in any other class protected by federal state or local law.
The companys continued success depends on the full and effective utilization of qualified individuals. Therefore harassment is prohibited and all matters related to recruiting training compensation benefits promotions and transfers comply with equal opportunity principles and are nondiscriminatory.
Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment please call 888.692.2272 or email . We will make accommodation determinations on a requestbyrequest basis. Messages and emails regarding anything other than accommodations requests will not be returned
Accessibility Policy
AmerisourceBergen is committed to fair and accessible employment requested AmerisourceBergen will accommodate people with disabilities during the recruitment assessment and hiring processes and during employment.
Salary Range*
Affiliated Companies:
Required Experience:
IC
Employment Type
Full-Time
