Description:
Pharmacovigilance Specialist
Remote
Until end of the year (possible extension)
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 client 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.
Essential Functions/Responsibilities
Provide operational support to risk management activities for Client 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.
Required Knowledge, Skills, and Abilities
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.
Proven ability to demonstrate client values.
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.
Required/Preferred Education and Licenses
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. Canadian PV experience preferred.
Operations experience with Compliance (preferred) and/or Quality Assurance.
Excellent organizational skills with keen attentiveness to detail; project management experience desired.
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.
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