The Drug Safety Risk Management (DSRM) Drug Safety Associate (DSA) will be responsible for adverse event (AE) and serious adverse event (SAE) report receipt, assessment, tracking, and workload distribution activities from all sources. This person will manage incoming and outgoing departmental communications including submission of expedited reports. Safety database data entry, report generation, and search capabilities are required. Close interaction with other members of DSRM is expected.

Receive, track, and assess AE and SAE reports from all sources including post-marketing, clinical trial, and literature sources.

Independently evaluate case source, adverse event, and patient information to determine report status (initial vs. follow-up) by executing data queries within the safety database.

Assess report for completeness and enter all applicable data into safety database including medical history, suspect/concomitant drug, source, and patient demographics.

Distribute, monitor, and evaluate departmental workload of individual case safety reports. Communicate any issues with responsible manager(s) and offer solutions.

Contact reporters to obtain follow-up information for reports.

Reconciliation of AE reports in the safety database with outside clinical research organization (CRO) databases, partner databases, and other sources. Ensure timely and adequate resolution of any discrepancies.

Manage Safety Outlook mailbox, log incoming documents, respond to inquiries, and forward relevant information to the appropriate person.

In coordination with other DSRM members prepare, submit, and track paper and electronic (E2B) expedited reports to regulatory agencies and partner companies including 15-day Alert Reports, 7/15-day IND Safety Reports, Investigator Letters, and Serious, Labeled Expedited Reports to comply with applicable global regulations and safety data exchange agreements.

Assists in the preparation of U.S. Periodic Reports, International Periodic Safety Update Reports, IND Annual Reports, and E.U. Annual Reports to ensure departmental compliance with all periodic and annual safety reporting requirements.

Electronic and hard copy document management, retrieval, and archiving of Drug Safety information including reports to partners, CROs, and health authorities.

Report to Senior Manager, Drug Safety Risk Management

Bachelor’s degree in a scientific discipline preferred.

6 months to 2 years of relevant experience in the healthcare, clinical or bio-pharmaceutical field, or other related experience; direct experience in a pharmaceutical or biotechnology company Drug Safety Department preferred.

Knowledge of medical terminology desirable.

The ideal candidate should have a general understanding of drug development, basic Drug Safety reporting, and working knowledge of the importance of regulatory compliance.

Strong computer and database skills, experience with Drug Safety databases desired; ARISg database experience a plus.

Strong organizational, oral/written communication and project management skills.

Requires strong attention to detail and a high commitment to the quality of all projects and accountability for deliverables.

Demonstrated ability to manage multiple projects and prioritize.

Ability to solve complex problems and suggest creative solutions.

Proactive, positive approach to work projects and constructive, supportive interactions with colleagues.

InterMune is an equal opportunity employer.

Please reference requisition number: DS 08012 when applying for this position.