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 DetailsPrincipales Fonctions et Responsabilites:

• Recevoir, numxc3xa9riser et documenter tous les renseignements cliniques pertinents en conformitxc3xa9 avec la PON/protocoles et les lois applicables;
• Travailler directement avec les clients internes et externes pour demander des renseignements additionnels ou des prxc3xa9cisions, selon les besoins;

• Examen des documents de donnxc3xa9es sources (y compris lxe2x80x99examen des rapports de visite RPP/PIR) et triage des informations sur les xc3xa9vxc3xa9nements indxc3xa9sirables et des plaintes sur la qualitxc3xa9 des produits en fonction des besoins des clients;
• Saisie des donnxc3xa9es et saisie des informations sur les xc3xa9vxc3xa9nements indxc3xa9sirables et des plaintes relatives xc3xa0 la qualitxc3xa9 des produits dans les bases de donnxc3xa9es spxc3xa9cifiques au programme;
• Tri et classement des documents entrants;
• Effectuer un contrxc3xb4le de la qualitxc3xa9 des rapports dxe2x80x99xc3xa9vxc3xa9nements indxc3xa9sirables conformxc3xa9ment aux instructions de travail;
• Assister ou effectuer les txc3xa2ches de vxc3xa9rification des donnxc3xa9es sources;

• Examiner la littxc3xa9rature mxc3xa9dicale et scientifique pour trouver des informations sur lxe2x80x99innocuitxc3xa9;
• Prxc3xa9paration des rapports de rapprochement (hebdomadaires, mensuels, etc.);
• Activitxc3xa9s de transcription, de traduction et de rxc3xa9daction;
• Prxc3xa9paration et rxc3xa9alisation de lettres de suivi sollicitxc3xa9es et de clarifications de donnxc3xa9es;
• Assister et participer au processus de non-conformitxc3xa9/ACAP.

• Lxe2x80x99associxc3xa9 de la pharmacovigilance se verra xc3xa9galement confier d'autres fonctions et txc3xa2ches au besoin, de temps xc3xa0 autre.
• Dans le cadre de ce poste, il peut xc3xaatre nxc3xa9cessaire de travailler sur demande ou xc3xaatre en disponibilitxc3xa9.

Experience et Scolarite Requises:

• Niveau d'xc3xa9tudes collxc3xa9giales minimum requis; Un diplxc3xb4me ou un diplxc3xb4me avec une concentration en sciences de la vie est un atout important;
• 1 xc3xa0 3 ans dxe2x80x99expxc3xa9rience dans le domaine de lxe2x80x99information mxc3xa9dicale, de la recherche clinique ou de lxe2x80x99innocuitxc3xa9 des mxc3xa9dicaments, ou une expxc3xa9rience xc3xa9quivalente et connexe en pharmacie ou dans le domaine pharmaceutique
• Connaissance de lxe2x80x99industrie de la pharmacovigilance, y compris une connaissance xc3xa0 jour des directives de pharmacovigilance de Santxc3xa9 Canada, de la FDA, de la EMEA et de l'ICH;
• Capacitxc3xa9 dxe2x80x99adaptation au changement et volontxc3xa9 dxe2x80x99acquxc3xa9rir de nouvelles compxc3xa9tences au besoin;

• Une expxc3xa9rience dans le domaine mxc3xa9dical ou pharmaceutique est un atout;
• Le bilinguisme (anglais/franxc3xa7ais) est un atout;
• Capacitxc3xa9 de travailler un quart de travail de 8 heures entre 8 h et 20 h, le cas xc3xa9chxc3xa9ant.

Competence Minimales, Connaissances et Aptitudes Requises:

• De solides aptitudes dxe2x80x99analyses;
• Capacitxc3xa9 de communiquer efficacement oralement et par xc3xa9crit;
• Compxc3xa9tences interpersonnelles efficaces;
• Sens de lxe2x80x99organisation; capacitxc3xa9 xc3xa0 effectuer plusieurs txc3xa2ches xc3xa0 la fois;

• Un souci du dxc3xa9tail supxc3xa9rieur et dxc3xa9montrxc3xa9;
• Capacitxc3xa9 xc3xa0 respecter les xc3xa9chxc3xa9ances de faxc3xa7on systxc3xa9matique;
• Excellentes aptitudes en rxc3xa9solution de problxc3xa8mes; facilitxc3xa9 de communication et capacitxc3xa9 xc3xa0 rxc3xa9soudre les problxc3xa8mes de faxc3xa7on efficace et efficiente;
• Connaissances informatiques (incluant : Microsoft Word, Excel, PowerPoint et dxe2x80x99autres programmes Office);
• Un bon accxc3xa8s xc3xa0 l'Internet est nxc3xa9cessaire pour le txc3xa9lxc3xa9travail.

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 follow-up letters and data clarifications
• Assist and participate in the non-conformance/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;
• 1-3 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 is an asset.
• Able to work any 8-hour shift between 8:00 AM-8 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 problem-solving 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 English-speaking customers, patients or peers from cross-functional teams.Le candidat retenu aura/pourrait avoir des contacts quotidiens avec des clients, des patients ou des pairs unilingues anglophones d'xc3xa9quipes interfonctionnellesWhat Cencora offersWe provide compensation, benefits, and resources that enable a highly inclusive culture and support our team membersxe2x80x99 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 timeEqual Employment OpportunityCencora 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 companyxe2x80x99s 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 non-discriminatory.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 request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returnedAccessibility PolicyCencora is committed to fair and accessible employment practices. When requested, Cencora will accommodate people with disabilities during the recruitment, assessment and hiring processes and during employment.Affiliated Companies: Affiliated Companies: Innomar Strategies

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