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Drug Safety Associate


The Drug Safety Associate provides expertise and support to drug safety operations (clinical trials) activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs). The employee is responsible for case processing activities (eg. safety database set-up, case triage, data entry, coding review, and narrative writing) in compliance with company procedures and regulatory requirements. 

 

RESPONSABILITIES

 

  • Reviews incoming sites’ SAE reports for completeness and validity, performs data entry of case reports into Argus safety database, requests follow-up and performs query management, performs coding of data, writes case narratives/regulatory reports (CIOMS/Medwatch).
  • Supports submission to agencies.
  • Responsible for setting-up and maintaining the Argus safety database.
  • Responsible for evaluating clinical database for non-reported adverse events, and their follow-up.
  • Participates in the development of Safety Management Plans (SMP) including the SAE and Pregnancy forms and Medical Monitoring Plans (MMP).
  • Prepares for and attend safety/pharmacovigilance kick-off meetings and investigator meetings.
  • Assists Data Management group in coding review to ensure correct categorization of medical terms (AE, medical history, prior/concomitant medications) in accordance with MedDRA and WHODRUG dictionaries.
  • Performs oversight of outsourced pharmacovigilance activities for individual case safety report (ICSR) processing and reporting in compliance and quality according to company procedures and regulatory requirements; performs quality control review of documents prepared by vendors.
  • Supports Medical Monitors during study conduct by reviewing potential issues and safety signals, and contributes to the safety governance process through the preparation and presentation of safety data/signal review spreadsheet for ongoing periodic safety data reviews.
  • Submits pharmacovigilance documentation to the Trial Master File.
  • Assists the Scientific team and the Regulatory Affairs groups as needed, including review of dermatology literature and writing/review of CSR narratives.
  • Collaborates in the development of drug safety’ practices, improvement initiatives, databases, tools, processes, and training materials.

PROFILE

 

Education

  • Degree in life science and/or healthcare-related field;

 

Experience

  • At least 3 years of experience in pharmacovigilance operations such as case processing, safety database maintenance, data entry, surveillance activities in a CRO/pharmaceutical clinical research environment;
  • Experience with Argus safety database an asset.

 

Knowledge and skills

  • Understanding of regulations related to pharmacovigilance and safety processes;
  • Knowledge and understanding of medical terminology/MedDRA/Who DRUG;
  • Business level proficiency in English; French an asset;
  • Excellent computer skills (Microsoft Word, Excel, Outlook);
  • Excellent organizational skills and sense of urgency/working to tight timelines;
  • Structured with a high attention to details;
  • Demonstrated ownership of projects and tasks;
  • Client-focused attitude;
  • Versatile and comfortable in a multitasking environment;
  • Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.

The work environment

 

At Innovaderm, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. 

As a Clinical Scientist, you will be eligible for the following perks: 

  • Flexible work schedule
  • Permanent full-time position
  • Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities)
  • Offices near public transportation (Sherbrooke metro station or Saint-Laurent metro station)
  • Possibility of working from home in accordance with company policies and public health directives
  • Ongoing learning and development

 

About Innovaderm

 

Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Innovaderm continues to grow and expand in North America and Europe.

 

Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. 

 

Innovaderm only accepts applicants who can legally work in Canada. 

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