Description
Role Overview: Conducts QC activities on Individual Case Safety Reports (ICSRs) ensuring accuracy, internal consistency, and compliance with SOPs, SJAs/WI, and regulatory guidance.
Responsibilities:
- Provides ongoing analysis of data resulting from the quality review of regulator ICSRs/aggregate reports produced by PSSR
- Supports/promotes accuracy, internal consistency, and compliance with guidance documents and regulatory expectations
- Knowledge of global regulatory requirements relative to pharmacovigilance, regulatory submission requirements, electronic reporting requirements and other relevant regulatory requirements and guidances
- Provides support for regulatory inspections, internal audits and/or strategic quality initiatives
- Develops and maintains an understanding of Pfast, and case processing activities so as ensure the accuracy of ICSRs, aggregate reports, ad hoc reports and analyses
- Compiles and analyzes ICSR data quality metrics on a routine basis to ensure consistency within cases and correctness of the data relative to the Users Reference Guide, Safety Job Aids (SJAs), and regulatory expectations
- Participates in quality activities, setting the standard for enhanced collaboration, delivery of project commitments and customer satisfaction
- Participates independently, as appropriate, in the ongoing review of processes related to the collection and analysis of safety information within PSSR
- May serve as a subject matter expert working with PSSR on training, knowledge sharing, technology, or specific work processes, providing advice and guidance as appropriate
Qualifications:
- BS or PharmD degree (or equivalent). Pharmacy or Nursing degree is preferred.
- Minimum of 3 years experience in clinical, safety and/or regulatory areas in the pharmaceutical/healthcare industry.
- Experience in quality control and/or quality assurance within the pharmaceutical industry preferred.
- Knowledge of global safety regulations and guidelines, or equivalent.
- Demonstrated strength in analytical skills and attention to detail.
- Demonstrated strength in oral/written communication and interpersonal skills.
- Demonstrated organizational/project management skills.
- Ability to make decisions independently and resolve issues appropriately.
- Demonstrated computer literacy, particularly in the use and management of relational databases.
TECHNICAL COMPETENCIES:
- Demonstrated ability to understand and consider competitive positioning when solving problems and making decisions.
- Demonstrated knowledge of clinical research and development processes, safety or regulatory requirements.
- Applies technical and line knowledge of key concepts in own discipline and may act as a key technical resource within the line.
- Knowledge of organizational development principles and demonstrated success in developing and implementing organizational development strategies.
- Demonstrated ability to manage complex projects and cross-functional processes and to meet established deadlines.
- Strong platform skills evident.
- Demonstrated ability to effectively work on simultaneous complex projects/deliverables.
- Demonstrated analytical and statistical skills.
- Thorough understanding of system technologies that support the business.
BEHAVIORAL COMPETENCIES: - Considers stakeholders, including regulatory agencies and safety, in developing strategies and future directions.
- Has extensive knowledge of the principles, concepts, and theories of the discipline, and working knowledge of principles and concepts of other disciplines.
- Embraces creativity, supports and takes well conceived risks and pursues new opportunities.
- Applies ethical standards, demonstrates open, honest, and ethical behavior, and inspires trust.
SKILLS
- Licensed Registered Nurse (RN), PharmD
Synectics is an Equal Opportunity Employer.