Director, Drug Safety and Pharmacovigilance

Position Summary

Essential Responsibilities

• Direct pharmacovigilance activities through identification, communication and documentation of new processes (e.g., quarterly data review meetings).  
• Author/revise SOPs and Work Instructions as appropriate.
• Determine initial internal staffing requirements to support drug safety and pharmacovigilance activities for the clinical programs assuming an external source (Vendor) will hold the databases.  
• Train internal staff and external vendors on drug safety policies and procedures. 
• Direct and manage the outsourced pharmacovigilance function;
• - Oversight and review of the vendor’s processing of Individual Case Safety Reports (ICSRs), including adherence to the Safety Management and Operational Plans.
• - Oversight and review of safety-related plans with CROs and partners.
• Develop a broad pharmacovigilance program to monitor safety data from clinical studies and post-approval, including reports from Investigator-Initiated studies, Medical Affairs sponsored activities and sentinel review of safety information reported in the literature.
• Identify third party vendor to hold and manage the organizations safety data base and support pharmacovigilance activities. 
• Support activities related to the review, analysis and summarization of safety data for inclusion in clinical documents such as the Investigator Brochure and periodic reports to regulatory authorities. Participate in signal detection efforts of a structured surveillance program. This includes collaboration with Clinical Development on regularly scheduled and ad-hoc reviews of emerging safety data for potential inclusion in Reference Safety Information (RSI).
• Perform on-going evaluation of reports of suspected, unexpected and related serious adverse drug reactions (SUSARs) and provide analyses of similar events (ASE) for incorporation into Investigational New Drug (IND) safety reports to the Regulatory Authorities, Institutional Review Boards and Ethics Committees.
• Participate, as needed, in reconciliation of clinical and safety databases for on-going studies. This involves activities such as overseeing the generation/resolution of SAE queries and MedDRA coding and data quality reviews. 
• Work with medical writers, as needed, in the preparation of patient narratives and safety data analyses for safety sections of Clinical Study Reports and summary documents. 
• Participate in investigations of reported Product Quality Complaints.
• Maintain up-to-date on worldwide Drug Safety regulations and industry standards and advise the company on any needed changes to internal capabilities.
• As needed, support the development, implementation and assessment of a Risk Evaluation and Mitigation Strategy (REMS) within a comprehensive risk management plan for marketed products. 

Education and Experience Requirements

• 10 years industry experience in drug safety and experience building Drug Safety Department.
• Knowledge of US and ex-US safety reporting requirements.
• Expertise in pharmacovigilance, pharmaco-oncology and therapeutic risk management
• Proven ability to work as a collaborative member of the management team.
• Strong people management skills – ability to lead, develop and motivate a team.
• Collaborative, team-oriented mindset with strong verbal and written communication skills. 
• Self-motivated, detail-oriented leader with exceptional organizational, leadership and interpersonal skills.

Industry

• Biotechnology

Employment Type:

• Consultant

Equal Employment Opportunity