Senior Drug Safety Specialist

Job Summary:

Reporting to the Senior Director of Drug Safety and Pharmacovigilance Operations, Senior Drug Safety Specialist, Contractor, of Drug Safety and Pharmacovigilance Operations (DSPV) will play a key role in drug safety Individual Case Safety Report processing across the clinical development and post marketing programs. The Senior Drug Safety Specialist, Contractor, DSPV Operations contributes to the day-to-day operational activities of the department and ensures that performed tasks comply with DSPV SOPs and policies, best industry standards and applicable regulations.

Responsibilities:

• Participate in assigned clinical study team meetings to provide pharmacovigilance support.
• Liaison with DSPV Operations and other Blueprint teams (i.e. study teams) on execution of study deliverables (i.e. study start up, safety management plans, SAE reconciliation, query management, TMF), aggregate reporting and post marketing activities, as required.
• Participated in sponsor oversight of Adverse Event/Serious adverse event processing and reconciliations by outsourced vendors, including the review of Individual Case Safety Report processing (case triage, data entry, coding review, sponsor approval and narrative writing), as well as monitoring of Individual Case Safety Report reporting within the Company Sponsored Safety Database.
• Supports monitoring of Quality of vendor of Individual Case Safety Report processing for clinical and post marketing cases
• Support the monitoring and performing of notification and/or submissions for Individual Case Safety Reporting for Clinical Trial submission cross functionally (e.g. CRO, Partner, Clinical, and/or Regulatory) with DSPV Systems Team
• Support DSPV Compliance with monitoring reports (i.e. KPI) and other oversight activities and ensure the implementation of effective corrective and preventative action plans.
• Supports the quality management system in Drug Safety including ensuring department standards are met, including training requirements, monitoring performance, implementing continuous improvement actions and good documentation practices.
• Supports the daily management and execution of Drug Safety and Pharmacovigilance operations cross functionally.
• Additional safety related duties assigned.

Qualifications:

• Bachelor’s degree in nursing, pharmacy, or other health care related profession or life sciences.
• Master’s or Doctorate level degree in health care related profession preferred, but not essential
• Minimum of 3 years of Drug Safety/Pharmacovigilance case process in a pharmaceutical industry setting.
• Prior experience working with CROs, vendors, and relationship management preferred.
• Global pharmacovigilance operations experience with products in development.
• Previous experience with ICSR workflow steps and Safety database (LSMV/ARISg preferred), MedDRA coding and data entry experience and data entry conventions.
• Knowledge of ICH Good Pharmacovigilance Practices and Good Clinical Practices.
• Anticipate and proactively resolve issues when and where possible.
• Knowledge of FDA and EU legislation and ICH Efficacy guidelines.
• Strong analytical, problem-solving skills with superb attention to detail, and able to organize workload to prioritize most urgent deliverable.
• Strong verbal, written technical communication and presentation skills.
• Must work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within an organization.
• Proven ability to work within a cross-functional, matrixed team.