DRUG SAFETY/PHARMACOVIGILANCE OPERATIONS
The Associate Director/Director of Drug Safety will provide drug safety operational expertise and guidance to clinical development and to Project Teams and will oversee strategic and tactical planning for all ICSR reports and periodic safety reports. Major areas of responsibility will include ensuring proper quality processes are in place to provide oversight of quality and compliance of vendor deliverables, with focus on adverse event case management; evaluating emerging safety data and, ensuring timely submission of reportable events to relevant regulatory authorities based on global or local laws and regulations, including trending on root causes for late ICSR and aggregate report submissions to health authorities.
This position will report to the Director of Drug Safety
RESPONSIBILITIES:
- Lead the ongoing process enhancements for safety operations, including development of standard operating procedures and work instructions and templates
- Establish the necessary quality control and monitoring processes to ensure compliance of service providers' work relating to adverse event case management
- Support audits/inspections of safety systems and procedures to ensure quality, integrity and compliance with pharmacovigilance and safety reporting regulations, including authoring of responses to regulatory findings relevant to safety operations and processes
- Liaison with partner company's drug safety team and clinicians and provide regular safety summaries as required
- Effectively executes on risk/project/document management, regulatory compliance, training and development, internal audits, inspections, and compliance programs to impact success of the company
- Provide strategic direction and leadership in the development and maintenance of compliance metrics and effectiveness measures
- Ensure accuracy and timeliness of submission of expedited reports from clinical trials
- Participate in SOP updates, audits, and inspections
- Conduct data analysis and other ad hoc activities
- Write/update core safety information for assigned projects
- Provide oversight quality control, compliance monitoring, and facilitate periodic report of these projects
- Assist and coordinate the development of periodic safety report, including DSUR, PBRER or other safety related reports as applicable
- Participate in cross-functional project teams; provide safety update and ensure adequate safety support cross functionally
- Ensure accuracy and timeliness of submission of expedited reports from clinical trials
- Maintain clinical and technical expertise in the therapeutic areas in which operates (i.e. through review of scientific journals, attend scientific and key technical meetings etc.)
- Assist in accomplishing department and corporate objectives
- Other duties as assigned
REQUIREMENTS:
- PharmD, RPh, PhD, MPH, or RN with requisite experience
- 8/10 years' experience in drug safety including the early phases of product development.
- Drug safety operational experience or clinical drug safety including risk/benefit analysis and safety assessment
- Strong working knowledge of US and ex-US pharmacovigilance regulatory requirements (e.g., US Code of Federal regulations; European Union GVP legislation; and ICH Guidelines)
- Successful experience managing complex safety issues arising in clinical trials
- Demonstrates excellent attention to detail, maintains confidentiality; maintains meticulous attention to project deadlines
- Strong proficiency in verbal and written communication
- Outstanding teamwork and ability to build successful relationships at all levels
- Able to work independently, establishing work priorities and direction
- Ability to be flexible/adaptable to the needs of the organization
- Meticulous attention to, and timely delivery on project deadlines
- Ability to be productive and successful in an intense work environment
