Director, Pharmacovigilance at New Brunswick

Director, Pharmacovigilance

Job Summary:

Seeking a Director of Pharmacovigilance for our clients Northern New Jersey site. This role provides oversight of the case processing function, including the mngmt. of workload, staff & associated processes & ensuring compliance & Quality of the teams deliverables.

Responsibilities:

Assess and manage workload and resources regularly to maintain regulatory compliance and quality. Eval. metrics reports and provide updates to mngmt. often. Implement processes to ensure accountability at all levels within case processing.

Author and review case processing SOPs and SOIs.

Oversee role in supporting global aggregate reports: PSUR & DSUR, & requests from license partners.

Provide support to project teams, including oversight of quality of SAE processing work performed by CROs.

Provide support for co. initiatives in establishing standards for study protocol template/safety section, SAE reconciliation, and CRF standards..

Job Requirements

Min: B.S. in nursing or pharmacy or health-related field

Min: 7 yrs. of pharmacovigilance exp., including exp. in a mngmt. role.

Solid sense of ownership and commitment to excellence;

Excellent organizational skills;

Excellent written and verbal communication skills;

Ability to work in a team environment;

Strong people management skills;

Efficient in time management and multi-tasking.

Knowledge of FDA regulations, ICH guidelines and GCP;

Knowledge of various safety databases

Solid Knowledge of how pharmacovigilance impacts other aspects of Risk Management.

For immediate consideration please email resume to Lisa G. -LisaG@scientificsearch.com

Country: USA, State: New Jersey, City: New Brunswick, Company: Scientific Search.