- 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.
- 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.
- 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.
- 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
- 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
- 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
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Associé Bilingue de la Pharmacovigilance - Oakville, Canada - Innomar Strategies
Description
Cherchez-vous à faire une différence dans la vie d'un patient? Chez AmerisourceBergen, vous trouverez une culture innovante et collaborative, axée sur le patient et soucieuse de faire la différence. En tant qu'organisation nous sommes unis par notre responsabilité d'œuvrer pour des vies plus saines. Joignez-vous à nous et postulez dès aujourd'hui
Ce que vous ferez
PRINCIPALES FONCTIONS ET RESPONSABILITÉS :
EXPÉRIENCE ET SCOLARITÉ REQUISES :
COMPÉTENCES MINIMALES, CONNAISSANCES ET APTITUDES REQUISES :
PRIMARY DUTIES AND RESPONSIBILITIES:
EXPERIENCE AND EDUCATIONAL REQUIREMENTS:
MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:
À quoi devraient ressembler vos antécédents
Ce qu'AmerisourceBergen offre
Nous offrons une rémunération globale concurrentielle. Notre engagement envers nos associés comprend l'offre de programmes d'avantages sociaux complets, diversifiés et conçus pour répondre aux divers besoins de l'ensemble de nos associés.
Grâce à notre présence mondiale et nos diverses unités commerciales, nous avons une approche équilibrée des avantages que nous offrons. De nombreux avantages sociaux sont payés par l'entreprise, tandis que d'autres sont offerts par les cotisations des associés. Les offres d'avantages sociaux spécifiques peuvent varier selon l'emplacement, le poste ou l'unité d'affaires.
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Temps PleinAffiliated Companies:
Affiliated Companies: Innomar Strategies
