Compliance & Analytics Consultant

RESPONSIBILITIES

- Combined with adherence to safety, regulatory, and project timelines, bridges partnership with customers to support "in line" quality ownership and participates in the development of efficient tools and techniques to support customers
- Plans, designs, and participates independently, as appropriate, in the ongoing review of processes related to the collection and analysis of safety information at the relevant site(s).
- Performs reviews of submission data and business processes/procedures to support continuous process improvement and organizational evolution, driving timely measurable and actionable feedback for proactive change.
- Performs quality review of compliance data.
- Manages the completion of complex tasks by applying technical skills, including but not limited to Excel and specialized knowledge to coordinate findings, conduct root cause analysis, and corrective action planning.
- Utilizes expertise of AE reporting and analysis, to develop/enhance the identification and investigation of causal candidates precipitating from root cause.
- Utilizes technology, including but not limited to Excel to increase efficiency and better ensure quality outputs.
- Participates in and contributes fully to project teams, task forces and or committees taking responsibility for timelines and deliverables for relevant business processes.
- May serve as a subject matter expert (or SME In-training) for Safety Evaluation Pharmaceutical experience.
- Knowledge of global regulatory requirements relative to pharmacovigilance, regulatory submission and electronic reporting requirements, and other relevant regulations and guidance.
- Strategic Thinking, Clinical, Regulatory and Safety Expertise, Technical Expertise, Scientific/Administrative Excellence, Organizational Development, Project and Process Management & meeting established deadlines, Presentation/Influencing/Organizational Skills, Multi-tasking, Team and Matrix Structure, Analytical and Statistical Skills, and Systems Technologies.
- Bachelor's degree in a science or business related discipline
- Training and/or demonstrated experience in relevant technical and behavioral competencies
- Advanced degree desired
- Clinical development and/or post-marketing and regulatory experience or related discipline
- Strong verbal, written, communication and presentation skills
- Innovative and strategic thinking ability 
- Strong computer skills desired
- Strong EXCEL skills
- Strong commitment to quality
- Strong commitment to data integrity.

Synectics is an Equal Opportunity Employer.