Job Description

Are you looking to make a difference in a patient\xe2\x80\x99s life? At AmerisourceBergen, you will find an innovative and collaborative culture that is patient focused and dedicated to making a difference. As an organization, we are united in our responsibility to create healthier futures. Join us and Apply today!

What you will be doing

PRINCIPALES FONCTIONS ET RESPONSABILIT\xc3\x89S:

Recevoir, num\xc3\xa9riser et documenter tous les renseignements cliniques pertinents en conformit\xc3\xa9 avec la PON/protocoles et les lois applicables;

Travailler directement avec les clients internes et externes pour demander des renseignements additionnels ou des pr\xc3\xa9cisions, selon les besoins;

Examen des documents de donn\xc3\xa9es sources (y compris l\xe2\x80\x99examen des rapports de visite RPP/PIR) et triage des informations sur les \xc3\xa9v\xc3\xa9nements ind\xc3\xa9sirables et des plaintes sur la qualit\xc3\xa9 des produits en fonction des besoins des clients;

Saisie des donn\xc3\xa9es et saisie des informations sur les \xc3\xa9v\xc3\xa9nements ind\xc3\xa9sirables et des plaintes relatives \xc3\xa0 la qualit\xc3\xa9 des produits dans les bases de donn\xc3\xa9es sp\xc3\xa9cifiques au programme;

Tri et classement des documents entrants;

Effectuer un contr\xc3\xb4le de la qualit\xc3\xa9 des rapports d\xe2\x80\x99\xc3\xa9v\xc3\xa9nements ind\xc3\xa9sirables conform\xc3\xa9ment aux instructions de travail;

Assister ou effectuer les t\xc3\xa2ches de v\xc3\xa9rification des donn\xc3\xa9es sources;

Examiner la litt\xc3\xa9rature m\xc3\xa9dicale et scientifique pour trouver des informations sur l\xe2\x80\x99innocuit\xc3\xa9;

Pr\xc3\xa9paration des rapports de rapprochement (hebdomadaires, mensuels, etc.);

Activit\xc3\xa9s de transcription, de traduction et de r\xc3\xa9daction;

Pr\xc3\xa9paration et r\xc3\xa9alisation de lettres de suivi sollicit\xc3\xa9es et de clarifications de donn\xc3\xa9es;

Assister et participer au processus de non-conformit\xc3\xa9/ACAP.

L\xe2\x80\x99associ\xc3\xa9 de la pharmacovigilance se verra \xc3\xa9galement confier d\'autres fonctions et t\xc3\xa2ches au besoin, de temps \xc3\xa0 autre.

Dans le cadre de ce poste, il peut \xc3\xaatre n\xc3\xa9cessaire de travailler sur demande ou \xc3\xaatre en disponibilit\xc3\xa9.

EXP\xc3\x89RIENCE ET SCOLARIT\xc3\x89 REQUISES :

Niveau d\'\xc3\xa9tudes coll\xc3\xa9giales minimum requis; Un dipl\xc3\xb4me ou un dipl\xc3\xb4me avec une concentration en sciences de la vie est un atout important;

1 \xc3\xa0 3 ans d\xe2\x80\x99exp\xc3\xa9rience dans le domaine de l\xe2\x80\x99information m\xc3\xa9dicale, de la recherche clinique ou de l\xe2\x80\x99innocuit\xc3\xa9 des m\xc3\xa9dicaments, ou une exp\xc3\xa9rience \xc3\xa9quivalente et connexe en pharmacie ou dans le domaine pharmaceutique

Connaissance de l\xe2\x80\x99industrie de la pharmacovigilance, y compris une connaissance \xc3\xa0 jour des directives de pharmacovigilance de Sant\xc3\xa9 Canada, de la FDA, de la EMEA et de l\'ICH;

Capacit\xc3\xa9 d\xe2\x80\x99adaptation au changement et volont\xc3\xa9 d\xe2\x80\x99acqu\xc3\xa9rir de nouvelles comp\xc3\xa9tences au besoin;

Une exp\xc3\xa9rience dans le domaine m\xc3\xa9dical ou pharmaceutique est un atout;

Le bilinguisme (anglais/fran\xc3\xa7ais) est un atout;

Capacit\xc3\xa9 de travailler un quart de travail de 8 heures entre 8 h et 20 h, le cas \xc3\xa9ch\xc3\xa9ant.

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\'\xc3\xa9quipes interfonctionnelles.

What your background should look like

What AmerisourceBergen offers

We offer a competitive total rewards package which includes benefits and compensation. Our commitment to our eligible population of team members includes benefit programs that are comprehensive, affordable, diverse, and designed to meet the needs of our team members\xe2\x80\x99 and their families. Some of these programs include paid time off including paid parental leave, access to retirement savings vehicles, medical, dental, vision, and life insurance options, an employee stock purchase program, and other financial, health, and well-being focused benefits.

Because we take a balanced, global approach to our benefits, benefit offerings may vary by location, position, and/or business unit. Some benefits are company-paid, while others are available through team member contributions. For details visit .

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Schedule

Full time

Affiliated Companies: Affiliated Companies: Innomar Strategies

Equal Employment Opportunity

AmerisourceBergen 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.

COVID-19 Vaccine Policy

As of October 18, 2021, AmerisourceBergen requires all Canadian team members to be fully vaccinated and show proof of completed vaccine status at time of hire. If you cannot receive the COVID-19 vaccine due to a qualifying medical condition or sincerely held religious belief you will be required to follow AmerisourceBergen\xe2\x80\x99s policy and process to apply for an exemption/accommodation.

Accessibility Policy

AmerisourceBergen is committed to fair and accessible employment practices. When requested, AmerisourceBergen will accommodate people with disabilities during the recruitment, assessment and hiring processes and during employment.

AmerisourceBergen