Senior Drug Safety Specialist


The Senior Drug Safety Specialist provides expertise and support to drug safety operations (clinical trials) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).

 

This role will be perfect for you if you:

  • have experience with management of clinical Individual Case Safety Reports (ICSRs) in Argus
  • have strong familiarity and experience with MedDRA and WHO Drug coding
  • have experience acting as system administrator for the safety database Argus
  • would appreciate the opportunity to coordinate some activities of the Pharmacovigilance (PV) team as a PV lead

 

More specifically, the Senior Drug Safety Specialist:

  • Performs drug safety activities for Phase 1-3 clinical trials: preparation/review of SAE and Pregnancy forms, SAE receipt and interaction with investigative sites, data entry of case reports into safety database, follow-up and query management, coding of clinical data, writing of case narratives including narratives for CSR/regulatory reports.
  • Performs QC review of documents prepared by vendors.
  • Prepares or participates in the review of Safety Management Plans (SMP) and the Medical Monitoring Plans (MMP).
  • Collaborates with the teams to facilitate safety/pharmacovigilance kick-off meetings; prepares and/or delivers drug safety-related presentations at investigator meetings, kick-off meetings, client meetings, and internal meetings as appropriate.
  • Participates in the maintenance and validation of hosted Argus Safety Database.
  • Assists Data Management group in coding of clinical data and medications; reviews and reconciles medical coding and terminology to ensure correct categorization of medical terms in accordance with specified medical dictionaries.
  • Supports Medical Monitors during study conduct by reviewing prohibited medications and contributes to the safety governance process through the preparation and presentation of safety data/signal review spreadsheet for ongoing periodic safety data reviews.
  • Performs filing such as submitting information to paper and electronic TMFs and filing documentation in the departmental working files.
  • Ensures the drug safety activities are delivered on time, within budget, and in compliance to SOPs and regulations.
  • Ensures adequate training of internal drug safety group and oversees practices to ensure alignment of practices across the team through adoption and use of all process and technology tools.
  • Collaborates in the development of drug safety’ practices, improvement initiatives, databases, tools, processes, and training materials.
  • Maintains familiarity with relevant current industry practices and regulatory requirements and guidelines.

 

REQUIREMENTS

 

Education  

  • University Degree in pharmacy, nursing, or healthcare discipline

 

Experience  

  • 2 to 5 years of experience in CRO/pharmaceutical clinical research environment in drug safety operations for clinical trials

 

Knowledge and skills 

  • Working experience with Argus Safety database;
  • Good knowledge of drug development process;
  • Knowledge and understanding of medical terminology; experience using MedDRA and WHODrug dictionaries;
  • Business level proficiency in English; other language is an asset;
  • Strong proficiency of Word and Excel;
  • 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.

 

OUR COMPANY

 

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. 

 

In this position, 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)
  • Ongoing learning and development

 

Work location 

The successful candidate for this position is given the option to work from home anywhere in Canada, or from our headquarters in Montreal (in accordance with company policies and public health directives).

Occasional visits to our Montreal headquarters may be required or encouraged.  

 

Covid-19 vaccination policy: The health and safety of all is important to us. In accordance with the applicable vaccination policy, Innovaderm demands that all employees present at its offices as well as all client and vendor sites (including clinical sites) be adequately vaccinated, under reserve of exemptions related to adaptation requirements prescribed by law.

 

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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