About this role
ProPharma has spent 25 years improving patient health and wellness by advising biotech, medical device, and pharmaceutical organizations. The company partners with clients through an advise-build-operate model across the full product lifecycle, delivering expertise in regulatory sciences, clinical research, quality and compliance, pharmacovigilance, and medical information.
The Pharmacovigilance Coordinator, Case Processing monitors and triages communications received via the PV inbox. This role performs data entry of clinical and post-marketing cases received by email or fax and generates deliverables from the safety database according to the safety management plan.
Daily work centers on managing assigned mailboxes, completing duplicate searches, screening source documents for PHI, and entering basic case data such as patient identifiers, suspect drugs, and adverse events. The coordinator also facilitates literature activities and distributes draft reports to clients when required.
ProPharma maintains a commitment to diversity, equity, and inclusion, encouraging employees to bring their authentic selves to work. All applications are personally reviewed by the recruitment team rather than screened by AI tools, and remote or hybrid arrangements are supported based on location and manager agreement.
Requirements
- Experience performing data entry of clinical and post-marketing cases in a safety database.
- Ability to triage and manage high volumes of PV inbox communications.
- Familiarity with redacting source documents for protected health information.
- Understanding of safety management plans and case processing deliverables.
- Capability to conduct duplicate searches and initial case book-in.
- Proficiency in supporting literature searches and regulatory authority database triage.
Responsibilities
- Manage assigned mailboxes, including inbox triage of client communication, inbound reports, and internal case processing communications.
- Perform duplicate searches and complete initial book-in as required.
- Screen and redact source documents for PHI as per company procedures.
- Facilitate literature-related activities as needed.
- Complete initial triage of regulatory authority database searches.
- Send draft reports to clients for review as needed.
- Enter basic data into the safety database, including identifiable patient, report, suspect drug, and adverse event information.
- Perform full data entry into the safety database when proper experience and training are in place.
Benefits
- Remote or hybrid work arrangements supported, with hybrid encouraged for those near an office.
- Commitment to diversity, equity, and inclusion with an environment where employees can be their authentic selves.
- All applications personally reviewed by a member of the recruitment team with no AI screening.
- Every applicant receives a direct outcome response from the company.
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