The PV Operations Manager will be responsible for core PV operational functions including Case Management, Alliance and Vendor Management, and Quality and Document Management. The individual will manage the operation infrastructure required to oversee all aspects of adverse event collection, processing, and reporting from clinical trials.
The individual will work collaboratively with the Executive Director of Pharmacovigilance and provide safety operational related guidance to Clinical Development and Operations, Data Management, and Biometrics.
- Direct and manage ICSR collection, processing and reporting activities, including associated quality and training activities to ensure regulatory timelines and global standards are met
- Reviews medical coding of AEs and medications for all clinical trials
- Ensures individual adverse case reports from all sources are collected, managed and reported according to Study Safety Management Plans and Standard Operating Procedures
Alliance and Vendor Management
- Provide oversight of the PV vendor performing case management and study support activities
- Lead the development of safety exchange agreements with license partners and distributors in support of PV collaborations
Quality and Document Management
- Oversee the creation of Safety Management Plans, Standard Operating Procedures and global adverse event regulations and guidelines
- Responsible for development and preparation of other reports for company management as well as external regulatory agencies, including Development Safety Update Reports (DSURS), Canadian Annual Reports (CARS), etc.
- Responsible for development and preparation of the safety sections of protocols, investigator brochures, clinical study reports, INDs, NDAs, and other documents to ensure that the documents are appropriate, feasible, operational and accurately reflect the safety and/or risk-benefit profile (as appropriate)
- Participate in regulatory inspections and audits to ensure the quality, integrity and compliance with pharmacovigilance and safety reporting requirements
Experience & Education
- Advanced scientific degree – RN, PharmD
- 8 or more years in drug development (pharmaceuticals, biotech or CRO), to include experience playing a leading role in PV operations
- 5 or more years in clinical research preferred
- Demonstrated strategic focus and problem-solving ability
- Substantial knowledge of drug development
- Thorough knowledge of ICH and GCP requirements
- Strong knowledge of Pharmacovigilance technologies
Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state and local laws governing nondiscrimination in employment.
To be considered as an applicant, please submit your resume/CV referencing the specific position of interest to [email protected].