BioPoint is currently seeking a qualified candidate to work as a Compliance Specialist in Horsham, PA. Candidate must be familiar with Root Cause Analysis of case safety reports.
In collaboration with other members of the Compliance Analytics Group, the Sr. Compliance Specialist is responsible for performing Root Cause Analysis of Late Individual Case Safety Reports for expedited cases to various Health Authorities. The Senior Compliance Specialist is also responsible for review and approval of single case deviation memos ensuring completion within specified timelines and that documentation of corrective actions is complete and robust.
Additionally, the Sr. Compliance Specialist may be responsible for one or more of the following areas: identification, evaluation, tracking and trending of global compliance issues, ensuring that relevant compliance information is provided to senior management and the QPPV Office, coordination of regulatory compliance tracking for specific products, and supporting compliance of Business Partners.
The Sr. Compliance Specialist will also prepare slides and metrics and other contributions for compliance meetings, participate in Compliance Meetings and perform ad hoc requests for compliance metrics and reports.
- Minimum of a Bachelors degree is required.
- Minimum of 3 years of pharmacovigilance experience is required
- Experience with Root Cause Analysis preferred
- Proficiency in leveraging data from databases and other sources is required
- The ability to utilize appropriate initiative and autonomy in achieving objectives and to work independently required
- Excellent verbal and written communication skills, strong interpersonal skills, good organizational skills and performance driven with good decision-making skills are all required for this role.
- Excellent analytical skills
- Proficiency in Microsoft Excel, PowerPoint and MS Word required
BioPoint Inc - 14 months ago
BioPoint, Inc. is a leading global strategic consulting firm that combines deep life sciences industry knowledge with...