BioPoint is seeking to hire a Sr. Pharmacovigilance Compliance Consultant in the Boston area.
- Oversight of compliance of Global Drug Safety department activities and Pharmacovigilance System activities, including those led by other departments such as Quality, Regulatory, Medical Affairs, etc.
- Lead for audit/inspection activities-both inspection room lead and backroom leadership as needed for FDA
- Perform investigation of deviations and monitoring of Corrective actions preventive actions (CAPA) relating to non-compliance issues and findings and propose appropriate long-term strategies to line management
- Track and communicate on compliance, Support Affiliates on compliance matters as required
- Ensure tasks and activities are performed according to the work instructions, procedures and Policies in place
- Interface with internal and external stakeholders and ensure that the appropriate contact points are established with the other groups (within Quality, Training &Compliance or outside) to respond and address gaps or compliance issues that need resolution by team specialists
- Excellent knowledge/experience of Compliance AND Pharmacovigilance is a MUST
- Good understanding of Corporate Pharmacovigilance Duties and Rules in a Pharmaceutical Company-Ability to identify proactively and anticipate risk of non-compliance in a complex environment
- Knowledge of compliance international Regulations and ICH environment foundations
- Good analytical/judgment capabilities to understand/analyze/synthesize and communicate- Project Management Abilities
- Able to manage both time and priority constraints and to manage multiple priorities simultaneously- Attention to details
- Proven ability to work in international environment and cross-functional team, with good interpersonal skills