Talent.com
Senior Clinical Trial Drug Safety Associate I
Senior Clinical Trial Drug Safety Associate IEverest Clinical Research • Markham, York Region, CA
Senior Clinical Trial Drug Safety Associate I

Senior Clinical Trial Drug Safety Associate I

Everest Clinical Research • Markham, York Region, CA
Il y a plus de 30 jours
Type de contrat
  • Temps plein
Description de poste

Senior Clinical Trial Drug Safety Associate I

Job Category : Pharmacovigilance and Drug Safety

Requisition Number : SENIO002258

  • Posted : January 14, 2025
  • Full-Time

Locations

Showing 1 location

Ontario

675 Cochrane Drive

East Tower 4th Floor

Markham, ON L3R0B8, CAN

Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Senior Clinical Trial Drug Safety Associate for our Toronto / Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy.

Key Accountabilities :

  • Assume a leader / mentorship role in the training of safety associates for PV and drug safety activities, ensuring compliance with PV processes and procedures as outlined in study level safety plans.
  • Receive safety monitoring projects and project information from the direct manager or from the work mentor for the assigned PV projects.
  • Perform PV and MDV activities for our clients in compliance with company SOPs, working practices, and regulatory guidelines.
  • Provide support to case processing of SAEs and / or pregnancy reports from clients’ ongoing drug clinical trials in a timely manner.
  • Participate in the design of SAE report forms for the capturing of safety data in clinical trials.
  • Provide operational support to study start-up PV activities, including authoring or peer review of SMPs and related attachments and forms.
  • Generate safety data listings or reports from Argus for assigned clients for periodic and ad hoc reporting.
  • Ensure compliance with all applicable regulations and timelines for safety case processing and reporting.
  • Act as a training resource to staff on case processing and the use of the Argus Safety System.
  • Qualifications and Experience :

  • BS (or equivalent) degree in Clinical or Medical or Life Sciences.
  • 4 years relevant work experience in Drug Safety / Pharmacovigilance in a pharmaceutical or CRO environment.
  • Comprehensive understanding of FDA, Health Canada, and / or EU legislation and GCP / GVP / ICH safety guidelines for investigational and marketed products.
  • Experience with safety case processing in clinical trials.
  • Prior experience with a safety database including case processing and generating reports / line listings from the database; Oracle Argus Safety database experience is preferred.
  • Ability to work independently with little supervision; self-motivated and productive.
  • Good organizational skills with the ability to adapt and adjust to changing priorities.
  • Strong verbal and written communication skills with the ability to understand and summarize medical terminology.
  • We thank all interested applicants, however, only those selected for an interview will be contacted.

    Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.

    #J-18808-Ljbffr

    Créer une alerte emploi pour cette recherche

    Clinical Associate • Markham, York Region, CA

    Offres similaires
    Clinical Research Associate II (Cell Therapy)

    Clinical Research Associate II (Cell Therapy)

    Nexcella, Inc. • Toronto, Ontario, Canada
    Temps plein
    Clinical Research Associate II (Cell Therapy).Greater Montreal Area / Hybrid.Our mission is to harness the immune system through innovative cell therapies and other modalities to deliver widely acc...Voir plus
    Dernière mise à jour : il y a 6 jours • Offre sponsorisée
    Director Health System Transformation & Strategy Realization - toronto

    Director Health System Transformation & Strategy Realization - toronto

    Innovative Medicines Canada - Médicaments novateurs Canada • toronto, on, ca
    Temps plein
    Feel free to email resumes to cvs@imc-mnc.Position Location : Ottawa or Toronto.Compensation : $122,000 - $167,500.ABOUT INNOVATIVE MEDICINES (IMC). Innovative Medicines Canada has an exciting opportu...Voir plus
    Dernière mise à jour : il y a 2 jours • Offre sponsorisée
    Risk and Regulatory Compliance Associate

    Risk and Regulatory Compliance Associate

    RSM US LLP • markham, on, ca
    Temps plein
    RSM is the leading provider of professional services to the middle market globally, our purpose is to instill confidence in a world of change, empowering our clients and people to realize their ful...Voir plus
    Dernière mise à jour : il y a 2 jours • Offre sponsorisée
    Sr. Clinical Trial Manager -Canada

    Sr. Clinical Trial Manager -Canada

    Syneos Health, Inc. • Toronto
    Temps plein
    Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into...Voir plus
    Dernière mise à jour : il y a 13 jours • Offre sponsorisée
    Senior Clinical Trial Drug Safety Associate I

    Senior Clinical Trial Drug Safety Associate I

    Everest Clinical Research • Markham
    Temps plein
    Senior Clinical Trial Drug Safety Associate I.Pharmacovigilance and Drug Safety.Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range ...Voir plus
    Dernière mise à jour : il y a 13 jours • Offre sponsorisée
    Senior Clinical Trial IWRS Monitor

    Senior Clinical Trial IWRS Monitor

    Everest Clinical Research Services Inc. • Markham
    Temps plein
    Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biote...Voir plus
    Dernière mise à jour : il y a plus de 30 jours • Offre sponsorisée
    Senior Local Trial Manager (2 Openings)

    Senior Local Trial Manager (2 Openings)

    Johnson & Johnson • Toronto
    Temps plein
    Clinical Trial Project Management.Remote (Canada), Toronto, Ontario, Canada.Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science‑based advancem...Voir plus
    Dernière mise à jour : il y a plus de 30 jours • Offre sponsorisée
    Senior Clinical Trial Analytics Monitor I

    Senior Clinical Trial Analytics Monitor I

    Everest Clinical Research Services Inc. • Markham
    Temps plein
    Senior Clinical Trial Analytics Monitor I.Ontario, 675 Cochrane Drive, East Tower 4th Floor, Markham, ON L3R0B8, CAN.Everest Clinical Research (“Everest”) is a full-service contract research organi...Voir plus
    Dernière mise à jour : il y a plus de 30 jours • Offre sponsorisée
    Senior Clinical Research Associate

    Senior Clinical Research Associate

    BeiGene • Toronto
    Temps plein
    BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals.When considering candidates, we look for scientific and business professionals who ...Voir plus
    Dernière mise à jour : il y a plus de 30 jours • Offre sponsorisée
    Associate Director, Healthcare & Pharmaceuticals, US Corporates - Toronto

    Associate Director, Healthcare & Pharmaceuticals, US Corporates - Toronto

    Fitch Group • Toronto
    Temps plein
    Associate Director – Healthcare & Pharmaceuticals.At Fitch, we have an open culture where employees are able to exchange ideas and perspectives, throughout the organization, irrespective of their s...Voir plus
    Dernière mise à jour : il y a 12 jours • Offre sponsorisée
    Senior Clinical Research Associate – Oncology Trials Leader

    Senior Clinical Research Associate – Oncology Trials Leader

    BeiGene, Ltd. • Toronto
    Temps plein
    A global biotechnology company is seeking a Senior Clinical Research Associate in Toronto.This role involves overseeing clinical study sites to ensure data quality and patient safety, along with me...Voir plus
    Dernière mise à jour : il y a 14 jours • Offre sponsorisée
    Clinical Trial Manager II : Lead Global Trials

    Clinical Trial Manager II : Lead Global Trials

    Syneos Health • Toronto
    Temps plein
    A leading biopharmaceutical solutions organization is looking for a Clinical Trial Manager II in Toronto.The successful candidate will oversee site management, ensure compliance with regulations, a...Voir plus
    Dernière mise à jour : il y a 14 jours • Offre sponsorisée
    Clinical Trial Assistant (Cell Therapy)

    Clinical Trial Assistant (Cell Therapy)

    Nexcella, Inc. • Toronto, Ontario, Canada
    Temps plein
    Clinical Trial Assistant (Cell Therapy).Greater Montreal Area / Hybrid.Our mission is to harness the immune system through innovative cell therapies and other modalities to deliver widely accessibl...Voir plus
    Dernière mise à jour : il y a 6 jours • Offre sponsorisée
    Senior Health & Safety Specialist

    Senior Health & Safety Specialist

    Riverside Natural Foods Ltd. • North York, ON, Canada
    Temps plein
    Join Riverside Natural Foods Ltd.Canadian-based, family-owned, and globally operating business, committed to leaving the world better than we found it. As a B-Corp certified, Triple-Bottom Line comp...Voir plus
    Dernière mise à jour : il y a 6 jours • Offre sponsorisée
    Associate Director, Healthcare & Pharmaceuticals, US Corporates - Toronto

    Associate Director, Healthcare & Pharmaceuticals, US Corporates - Toronto

    Fitch Group, Inc., Fitch Ratings, Inc., Fitch Solutions Group • Toronto, ON, Canada
    Temps plein
    Associate Director – Healthcare & Pharmaceuticals (Healthcare & Pharmaceuticals Sector).Category : Credit Analysis & Research. Fitch has an open culture where employees can exchange ideas across any ...Voir plus
    Dernière mise à jour : il y a 12 jours • Offre sponsorisée
    Associate Director, Healthcare & Pharmaceuticals, US Corporates - Toronto

    Associate Director, Healthcare & Pharmaceuticals, US Corporates - Toronto

    Fitch Ratings • Toronto
    Temps plein
    Associate Director – Healthcare & Pharmaceuticals (Toronto).Fitch Ratings is a leading provider of credit ratings, commentary and research. Dedicated to providing value beyond the rating through ind...Voir plus
    Dernière mise à jour : il y a 9 jours • Offre sponsorisée
    Senior Safety Auditor

    Senior Safety Auditor

    Metrolinx • Toronto
    Temps plein
    Metrolinx is connecting communities across the Greater Golden Horseshoe.Metrolinx operates GO Transit and UP Express, as well as the PRESTO fare payment system. We are also building new and improved...Voir plus
    Dernière mise à jour : il y a 3 jours • Offre sponsorisée
    Clinical Research Associate I (SRI) - Odette Cancer Centre Clinical Trials - Regular Full-time [...]

    Clinical Research Associate I (SRI) - Odette Cancer Centre Clinical Trials - Regular Full-time [...]

    Sunnybrook • Toronto
    Temps plein
    The Odette Cancer Center (OCC) Clinical Research program is part of Sunnybrook Research Institute’s (SRI) ongoing commitment to participate in innovative and high quality clinical research.Consenti...Voir plus
    Dernière mise à jour : il y a plus de 30 jours • Offre sponsorisée