I am partnered with an industry leading biopharma on a search for a Manager, Clinical Safety - reporting into the Director of PV.
This innovative bio-pharmaceutical company is dedicated to developing groundbreaking treatments for metabolic and liver diseases. Their research focuses on creating therapies that address significant unmet medical needs, aiming to improve the quality of life for patients worldwide. With a strong commitment to scientific excellence and patient care, they are at the forefront of advancing medical science in their field.
The Manager of Clinical Safety & Medical Operations will be instrumental in supporting the safety assessment, evaluation, and risk management of products at various development stages, as well as participating in safety surveillance activities.
Responsibilities:
- Review ICSRs (including case narratives, causality assessments, and coding) for assigned projects.
- Oversee clinical pharmacovigilance vendor activities, including assessment, evaluation, tracking, and reconciliation of safety information. Manage the monthly reconciliation process performed by the PV vendor.
- Assist with Data Monitoring Committee activities as needed.
- Support other PV compliance activities as required.
Qualifications:
- Minimum of 5 years of experience in drug safety and PV, including case quality control and regulatory submissions of ICSRs worldwide.
- Ability to interpret health and medical records such as adverse event reporting forms and discharge summaries.
- Experience with safety databases; familiarity with Argus is a plus but not mandatory.
