Sr. Case Specialist

Job Summary
Plays a key operational support role in the GRADS Global Risk Management Team, supporting the development, implementation, execution, and monitoring of risk management activities, assessments, and documents for company product(s) in Canada. This role will collaborate cross-functionally (e.g., with the Safety Management Team, QPPV, other functions, and affiliates) and will support process development, training, and continuous improvement efforts.

location: Telecommute

job type: Contract

salary: $ per hour

work hours: 9 to 5

education: Bachelors

Responsibilities

• Provide operational support to risk management activities for company products globally.
• Support the design, implementation, and/or evaluation of additional pharmacovigilance activities and additional risk minimization measures.
• Maintain awareness of regulatory intelligence pertaining to risk management.
• Represent Global Risk Management in cross-functional teams/forums.
• Develop/update processes and implement changes in collaboration with other business functions/affiliates in an evolving regulatory environment.
• Develop, coordinate, review, and/or maintain risk management plans and other documents that involve risk management (e.g., information requests, reports, safety data exchange agreements) in collaboration with other business functions/affiliates.
• Support data collection, analysis, and reporting for measuring effectiveness of additional pharmacovigilance activities and additional risk minimization measures.
• Identify trends and areas for improvement in risk management practices.
• Contribute to inspection readiness activities.
• Contribute to developing/updating training and communication materials, including delivering training or roadshows on risk management processes to other business functions to foster awareness of risk management practices.
• Provide support to global risk management team such as developing project timelines, preparing/archiving agendas, data, slides, and minutes.

Qualifications
Required:

• BA/BS, MS/MA degree required. Health-related or biological science-related field, PharmD, RPh, or Nursing strongly preferred.
• Minimum of 6 years in pharmacovigilance with risk management experience.
• Pharmacovigilance Operations experience
• Familiarity with PV databases and regulatory information management systems (e.g., Veeva RIM); data management/analysis experience and/or and computer system management experience are a plus.
• Experience with developing and/or managing process documents and/or change controls.
• Knowledge of current and emerging regulatory requirements and expectations pertaining to risk management.

Preferred

• Regulatory Compliance (preferred) and/or Quality Assurance experience

skills: Risk Management, Quality Assurance, Pharmacovigilance, MS-EXCEL

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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