- Accountable for recognizing Adverse Event (AE) / Adverse Drug Reactions (ADR) / Adverse Drug Experience (ADE), Medical Device Incident (MDI) information from the source document
- Accountable for Individual Case Safety Report (ICSR) processing as per applicable Standard Operating Procedures (SOPs) and Work Instructions (WI) including but not limited to Triage, Duplicate Search, Data Entry, MedDRA codding, Narrative Writing, Medical Evaluation, Seriousness assessment, expectedness assessment, Causality assessment, Reportability Assessment, Expedite, and Periodic submission, etc.
- Accountable to perform Literature Review as per the applicable organization's SOP and WI
- Accountable preparation and/or review of aggregate reports as per applicable SOP and WI including but not limited to Annual Summary Reports (ASR), Issue Related Summary Report (IRSR), Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Report (PBRERs), Periodic Adverse Drug Experience Report (PADER), Developmental Safety Update Report (DSUR), etc.
- Accountable for performing Signal Detection as per applicable SOP and WI Accountable for preparation and/or update of Risk Management Plan (RMP) or Risk Evaluation and Mitigation Strategies (REMS) and associated documents
- Accountable to act as a contact point for the client Work directly with internal and external stakeholders to request additional information or clarification as necessary;
- Assist in audit preparation File and store all documents as per applicable SOP and WI.
- Other tasks assigned by the Manager, as needed. May be required to be on standby / on-call as part of this role.
-
Pharmacovigilance Analyst
1 week ago
Cencora Oakville, Canada- What you will be doing · - PRIMARY DUTIES AND RESPONSIBILITIES: · - Accountable for recognizing Adverse Event (AE) / Adverse Drug Reactions (ADR) / Adverse Drug Experience (ADE), Medical Device Incident (MDI) information from the source document · - Accountable for Individual C ...
-
Pharmacovigilance Analyst
1 week ago
Innomar Strategies Oakville, ON, CanadaPharmacovigilance Analyst page is loaded · Pharmacovigilance Analyst · Apply locations Oakville, ON Remote, ON time type Full time posted on Posted 3 Days Ago job requisition id R248593 Our team members are at the heart of everything we do. At Cencora, we are united in our res ...
-
Pharmacovigilance Analyst
2 weeks ago
Innomar Strategies Oakville, Canada Full timeOur 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 ...
-
Pharmaceutical - Business Analyst
1 week ago
amaris Toronto, CanadaJob description · We are looking for dynamic consultants to grow our Life Sciences team in Toronto. Your experience, knowledge, and commitment will help us to face our client's challenges. · You will be supporting different projects through your expertise as Pharmaceutical - Busi ...
-
Pharmaceutical - Business Analyst
1 week ago
Amaris Consulting Toronto, Canada**Who are we? **:**Amaris Consulting** is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade - this is made possible by an ...
-
Pharmaceutical - Business Analyst
1 week ago
Amaris Consulting Toronto, CanadaJob description · We are looking for dynamic consultants to grow our Life Sciences team in Toronto . Your experience, knowledge, and commitment will help us to face our client's challenges. · You will be supporting different projects through your expertise as Pharmaceutical - ...
Pharmacovigilance Analyst - 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
PRIMARY DUTIES AND RESPONSIBILITIES:
À quoi devraient ressembler vos antécédents
EXPERIENCE AND EDUCATIONAL REQUIREMENTS:
Bilingual, English/French strongly preferred Bachelor's degree in a Pharmacy, Dental, Pharmacology, Nursing, or Medical Degree 3-4 years of experience in the Pharmacovigilance area of the pharmaceutical industry; Knowledge of medical terminology is a strong asset
MINIMUM SKILLS, KNOWLEDGE, AND ABILITY REQUIREMENTS:
Strong knowledge of the pharmacovigilance industry including up-to-date knowledge of Health Canada, US-FDA, and ICH's Pharmacovigilance requirements and guidelines Familiarity with MS Word, MS Excel, MS PowerPoint, other MS Office Programs, and Adobe Pro Familiarity with Good Documentation Practice (GDP) and Quality Management Systems (QMS) is an asset Strong business and financial acumen Strong analytical and mathematical skills Ability to communicate effectively both orally and in writing Effective interpersonal and leadership skills Effective organizational skills, attention to details Ability to consistently meet deadlines Excellent problem-solving skills; ability to resolve issues effectively and efficiently Excellent presentation skills Able to work any 8-hour shift between 8:00 AM-8 PM, if necessary Can-do attitude, with proven ability to meet strict deadlines
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.
Calendrier
Temps PleinAffiliated Companies:
Affiliated Companies: Innomar Strategies
