Case Management Scientist Lead

Contact: Alexandra Spink -

NO 3rd party agencies

Job Description: Reporting to the Pharmacovigilance Scientist Lead, the Case Management Scientist Lead will support the PV Team in the overall safety management of assigned clinical trials. The successful candidate will be an experienced, hands-on lead with a strong scientific background.

Responsibilities:

Monitors the electronic safety mailbox to include identifying, tracking, and filing AE, AESIs, Pregnancies and SAE information, as well as triage incoming adverse event reports.

Apply clinical knowledge and expertise to author in depth, thorough case narratives.

Perform follow up activities as required, including management of queries.

Collaborate with the Drug Safety Physician for the medical review of cases.

Perform quality checks on case processing activities and adverse event reports from external vendors.

Liaise with Data Management Lead to ensure that the SAE reconciliation process and EDC related SAE activities are set up per standard at study start up.

Qualifications:

5-10 years of experience of Drug Safety & Pharmacovigilance experience at a biotechnology, pharmaceutical company, or CRO.

Minimum of B.S. degree in nursing or pharmacy. BSN or PharmD preferred.

Must have demonstrated success working both independently and in close collaboration with others.

Clear and effective communication skills, excellent interpersonal skills.

Attention to detail and ability to multitask.

Demonstrated passion for the company’s values with a commitment to deliver results against our mission.

Experience with large scale global clinical trials preferred.

Experience working with Infectious Disease or Vaccines a plus.