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Director, Drug Safety and Medical Monitoring


 

Responsible for safety surveillance activities and the leadership of the global medical monitoring and pharmacovigilance teams, this person will provide hands-on and strategic input for activities related to medical monitoring and pharmacovigilance as well as support business clinical development strategies globally.

 

 

This role will be perfect for you if:

 

  • You act as a leader and can help a team rally behind objectives and do their best work
  • You are looking for a growing CRO where your ideas and input is welcomed and valued
  • You enjoy working in dermatology or would like to learn and develop within that therapeutic area.

 

 

RESPONSIBILITIES

 

Team leadership

 

  • Responsible for operational and strategic leadership of the department, including budget decisions.
  • Ensure that medical monitoring and pharmacovigilance operations are completed to the Sponsor’s satisfaction, ensuring quality deliverables on time, within budget and in accordance with applicable standard operating procedures (SOPs), regulatory requirements, and good clinical practices (GCP).
  • Participate and contribute to dermato-scientific governance committee meetings.
  • Oversee the performance and professional development of direct reports
  • Implement strategies for process improvement in alignment with industry best practices. Ensure processes, tools, systems and platforms support compliance, efficiency, as well as effective communication.
  • Ensure standardization of practices across the teams through adoption and use of all process and technology tools.
  • Develop Key Performance Indicators to demonstrate the volume, quality, and timeliness of the activities of the full team
  • Participate in the development, review, and approval of departmental SOPs.

 

 

Project support

 

  • Serve as a primary point of contact for Sponsors when issues must be escalated to ensure communication is maintained and resolution is achieved. Escalates to Senior Management, as necessary.
  • Manage reported and observed quality issues within the teams. Summarize findings and establish action plans to ensure resolution of quality issues for the department.
  • Support the Medical Monitors and the Pharmacovigilance group during study conduct by reviewing potential issues and contributing to the safety governance process and to risk management.
  • Review study-specific plans and documents relevant to the role of the teams.
  • Participate in kick-off meetings, audits, inspections, and other project related meetings according to the company / client needs.
  • Collaborate in the development of publications/presentations and trial results communication for Investigators.

 

 

Support of business development activities

 

  • Participate in the preparation of business development proposals, including feasibility discussions and Requests for Information (RFI).
  • Identify out-of-scope activities and support project teams with budget change order preparation.
  • Participate in bid defense meetings.

 

 

Medical Monitoring

 

  • May act as a Medical Monitor/Drug Safety Physician for assigned projects; responsible for the safety data review to ensure data integrity and subject safety oversight, and for communication with sites, Investigators, and internal project team members to ensure questions are promptly addressed. 

 

IDEAL PROFILE

 

Education 

 

  • Medical degree; dermatology specialty an asset.

 

Experience

 

  • 10+ years of relevant CRO/pharmaceutical industry experience (i.e., clinical research, pharmacovigilance, drug safety, medical monitoring)
  • Experience in dermatological clinical research is an asset;
  • Experience managing a team

 

Knowledge and skills

 

  • Team leadership abilities, including decision making and problem solving, people management and budgetary responsibility.
  • Knowledge of safety databases (ARGUS preferred) and medical terminology (e.g., MedDRA and WHODRUG).
  • Ability to analyze data to draw medical conclusions
  • Excellent knowledge of the drug development process.
  • Ability to influence stakeholders, reach consensus, and meet critical regulatory, safety and business objectives.
  • Ability to work in a high-speed environment with proven agility to juggle and prioritize multiple competing demands.
  • Fluency in English with excellent oral and written skills required; additional languages represent an asset
  • Excellent computer skills (Word, Excel, Power Point).
  • Client-focused approach to work.
  • 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. 

In this position, you will be eligible for the following perks: 

  • Flexible work schedule
  • Permanent full-time position
  • Complete benefits (medical, dental, vision, RRSP match, vacation, personal days, virtual medical clinic, social activities)
  • Performance bonus
  • 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. 

Occasional travel which may include overnight trips and / or international travel may be required as part of this role.

 

 

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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