What are the responsibilities and job description for the Sr. Case Specialist - Global Risk Management (Contractor) position at Advanced Clinical?
Overview
We are currently searching for a skilled professional to join a well-known client’s team as a Senior Case Specialist - Global Risk Management remotely in the United States. The Senior Case Specialist role will play a key operational support role in the Global Risk Management Team, supporting the development, implementation, execution, and monitoring of risk management activities, assessments, and documents for pharmaceuticals products in Canada. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
Responsibilities
Minimum of 6 years in pharmacovigilance with risk management experience. Canadian PV experience preferred.
EDUCATION
Bachelors or Masters degree required. Health-related or biological science-related field, PharmD, RPh, or Nursing degree strongly preferred.
To Be a Best-fit Your Strengths Must Include
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
We are currently searching for a skilled professional to join a well-known client’s team as a Senior Case Specialist - Global Risk Management remotely in the United States. The Senior Case Specialist role will play a key operational support role in the Global Risk Management Team, supporting the development, implementation, execution, and monitoring of risk management activities, assessments, and documents for pharmaceuticals products in Canada. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
Responsibilities
- Provide operational support to risk management activities for pharmaceuticals products in Canada.
- 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.
- Contribute to inspection readiness activities.
- 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 documents that involve risk management (e.g., information requests, reports, safety data exchange agreements) in collaboration with other business functions/affiliates.
- Provide support to global risk management team such as developing project timelines, preparing/archiving agendas, data, slides, and minutes.
- 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.
Minimum of 6 years in pharmacovigilance with risk management experience. Canadian PV experience preferred.
EDUCATION
Bachelors or Masters degree required. Health-related or biological science-related field, PharmD, RPh, or Nursing degree strongly preferred.
To Be a Best-fit Your Strengths Must Include
- Knowledge of current and emerging regulatory requirements and expectations pertaining to risk management.
- Knowledge of pharmacovigilance activities and processes. Strong experience with process development.
- Experience managing relationships with service providers or external business partners.
- Excellent teamwork and interpersonal skills with cross-functional team experience.
- Excellent oral and written communications skills.
- Willingness to take on new challenges/opportunities.
- Ability to work cross culturally both in person and virtually.
- Proficiency with MS Office.
- Familiarity with Smartsheet, Miro.
- Skill in inspiring and guiding others without formal authority.
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
