This position will be involved with worldwide pre- and post-marketing safety activities and will be responsible for assuring the processing and reporting of safety reports in compliance with SOP's, guidelines, and worldwide pharmacovigilance regulations. This position must effectively interface cross-functionally at all levels in the organization, as well as externally with vendors and corporate partners.
Assists with the receipt, confirmation, and processing of adverse event (AE) and serious adverse event (SAE) safety reports from multiple sources.
Ensures safety reports are booked in, triaged, evaluated, assessed, followed-up and closed per departmental procedures.
Ensures the uniform and timely processing of safety reports in accordance with SOPs and worldwide regulatory authority regulations.
Assists with the preparation of aggregate safety reports such as the Development Safety Update Report, Periodic Benefit Risk Evaluation Report, periodic line listings, ad-hoc analyses, etc. as assigned.
Liaises with vendors, contracted service providers, and corporate partners in order to ensure compliance with contracts and agreements related to safety case processing and reporting.
Maintains departmental and pharmacovigilance documentation in an audit-ready state and support audits/inspections.
Oversees activities associated with case processing such as SAE reconciliations, vendor reconciliations, submission compliance, and case QC, and case closure activities.
Assists with the development and maintenance of PV plans including safety management plans, regulatory reporting plans, and SAE reconciliation.
Other responsibilities as assigned.
Knowledge of GCPs, ICH guidelines and FDA regulations and familiarity with EMA regulations and guidelines, and other international regulatory requirements.
Knowledge of MedDRA dictionary relevant to AE/SAE coding
Experience with software-based drug safety systems (ARGUS experience is preferred)
Strong interpersonal and communication skills; proactive approach. Able to work both independently and in a team environment.
Detail-oriented, with good organizational, prioritization, and time management proficiencies. Must be able to work on multiple projects simultaneously.
Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures.
Proficient in standard computer software (Word, Excel and Power Point).
EDUCATION AND EXPERIENCE
At least 5 years of pharmacovigilance experience at a biotech, pharmaceutical, or CRO company. Safety case processing experience is required.
Bachelor's degree required in a health care discipline. BSN, PharmD, PA preferred.
Intercept Pharmaceuticals, Inc.