Associé Bilingue de la Pharmacovigilance, Bilingue /Bilingual Drug Safety Associate

Job title:

Associé Bilingue de la Pharmacovigilance, Bilingue /Bilingual Drug Safety Associate

Company

Cencora

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

• Examen des documents de données sources (y compris l’examen des rapports de visite RPP/PIR) et triage des informations sur les événements indésirables et des plaintes sur la qualité des produits en fonction des besoins des clients;
• Saisie des données et saisie des informations sur les événements indésirables et des plaintes relatives à la qualité des produits dans les bases de données spécifiques au programme;
• Tri et classement des documents entrants;
• Effectuer un contrôle de la qualité des rapports d’événements indésirables conformément aux instructions de travail;
• Assister ou effectuer les tâches de vérification des données sources;

• Examiner la littérature médicale et scientifique pour trouver des informations sur l’innocuité;
• Préparation des rapports de rapprochement (hebdomadaires, mensuels, etc.);
• Activités de transcription, de traduction et de rédaction;
• Préparation et réalisation de lettres de suivi sollicitées et de clarifications de données;
• Assister et participer au processus de non-conformité/ACAP.

• L’associé de la pharmacovigilance se verra également confier d’autres fonctions et tâches au besoin, de temps à autre.
• Dans le cadre de ce poste, il peut être nécessaire de travailler sur demande ou être en disponibilité.

Experience et Scolarite Requises:

• Niveau d’études collégiales minimum requis; Un diplôme ou un diplôme avec une concentration en sciences de la vie est un atout important;
• 1 à 3 ans d’expérience dans le domaine de l’information médicale, de la recherche clinique ou de l’innocuité des médicaments, ou une expérience équivalente et connexe en pharmacie ou dans le domaine pharmaceutique
• Connaissance de l’industrie de la pharmacovigilance, y compris une connaissance à jour des directives de pharmacovigilance de Santé Canada, de la FDA, de la EMEA et de l’ICH;
• Capacité d’adaptation au changement et volonté d’acquérir de nouvelles compétences au besoin;

• Une expérience dans le domaine médical ou pharmaceutique est un atout;
• Le bilinguisme (anglais/français) est un atout;
• Capacité de travailler un quart de travail de 8 heures entre 8 h et 20 h, le cas échéant.

Competence Minimales, Connaissances et Aptitudes Requises:

• De solides aptitudes d’analyses;
• Capacité de communiquer efficacement oralement et par écrit;
• Compétences interpersonnelles efficaces;
• Sens de l’organisation; capacité à effectuer plusieurs tâches à la fois;

• Un souci du détail supérieur et démontré;
• Capacité à respecter les échéances de façon systématique;
• Excellentes aptitudes en résolution de problèmes; facilité de communication et capacité à résoudre les problèmes de façon efficace et efficiente;
• Connaissances informatiques (incluant : Microsoft Word, Excel, PowerPoint et d’autres programmes Office);
• Un bon accès à l’Internet est nécessaire pour le télétravail.

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’équipes interfonctionnellesWhat Cencora offersWe 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 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 company’s 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

Expected salary

Location

Canada

Job date

Thu, 26 Dec 2024 06:46:12 GMT

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