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Drug Safety Associate

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Cencora

15d ago

  • Job
    Full-time
    Junior & Mid Level
  • Data
    Healthcare

AI generated summary

  • You need a college education in Life Sciences, 1-3 years in drug safety or related fields, knowledge of pharmacovigilance guidelines, strong analytical and communication skills, and attention to detail. Bilingualism is a plus.
  • You will document clinical information, review source data, manage adverse event reports, conduct quality checks, and assist with data reconciliation, follow-ups, and the non-conformance process.

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
  • 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

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

FAQs

What is the main responsibility of a Drug Safety Associate at Cencora?

The main responsibility includes receiving, scanning, and documenting clinical information, reviewing adverse event information, and maintaining compliance with relevant regulations and protocols.

What educational background is preferred for this role?

A minimum college level education is required, with a strong asset being a diploma or degree in Life Sciences.

How many years of experience are required for this position?

1-3 years of experience in Medical Information, Clinical Research, or Drug Safety, or related experience in pharmacy or pharmaceuticals is required.

Is knowledge of pharmacovigilance guidelines important for this role?

Yes, up-to-date knowledge of pharmacovigilance guidelines from Health Canada, US FDA, EMEA, and ICH is essential.

Are bilingual candidates preferred?

Yes, being bilingual in English and French is considered an asset.

What are the working hours for this position?

The position requires the ability to work any 8-hour shift between 8:00 AM and 8:00 PM, if necessary.

What key skills are necessary for a Drug Safety Associate?

Strong analytical skills, effective communication, organizational abilities, attention to detail, problem-solving skills, and computer proficiency are necessary for this role.

What benefits does Cencora offer to its employees?

Cencora offers a comprehensive suite of benefits, including medical, dental, and vision care, support for working families, professional development resources, and opportunities for mentorship and volunteer activities.

Does Cencora provide equal employment opportunities?

Yes, Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, or other protected classes.

What should I do if I need a reasonable accommodation during the application process?

If you require an accommodation, you can call 888.692.2272 or email hrsc@cencora.com to make a request.

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Cencora

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Cencora, a company building on the legacy of AmerisourceBergen, is a leading global pharmaceutical solutions organization centered on improving the lives of people and animals around the world. We connect manufacturers, providers, and patients to ensure that anyone can get the therapies they need, where and when they need them. We also help our partners bring their innovations to patients more efficiently to accelerate positive outcomes. Becoming Cencora has allowed us to combine all the companies and services of AmerisourceBergen. Now, as a unified and internationally inclusive brand, we’re continuing to invest in and focus on our core pharmaceutical distribution business, while also growing our platform of pharma and biopharma services to support pharmaceutical innovation and access. Our 46,000+ worldwide team members are shaping the future of healthcare through the power of our purpose: We are united in our responsibility to create healthier futures.