About the role

Senior Project Manager managing client programs and pharmacovigilance at Clinigen. Leading compliance and safety management to ensure project standards are maintained under regulations.

Responsibilities

Manage daily interaction with Clients, Sponsors and staff to assist in developing and implementing project-specific safety plans, safety documents, SOPs and guidelines to reflect specific work processes.
Assist with Safety Management Plan development and safety database configuration and ensure project team is up to date on all relevant changes.
Ensure that relevant data is entered and maintained in the safety database system in collaboration with the Medical/Safety business unit.
Ensure Pharmacovigilance files for assigned projects are properly maintained and/or provided to Records Management in a timely manner.
Manage communications between appropriate team members, Clients, and Sponsors when safety issues are identified.
Participate in training sessions and workshops, including presenting reports from any conferences attended, as agreed.
Monitor compliance metrics, project budgets, and service level agreements for assigned projects to ensure regulations and timelines are being met and activities performed are within the approved budget.

**Key Responsibilities:**
Manage daily interaction with Clients, Sponsors and staff to assist in developing and implementing project-specific safety plans, safety documents, SOPs and guidelines to reflect specific work processes.
Assist with Safety Management Plan development and safety database configuration and ensure project team is up to date on all relevant changes.
Ensure that relevant data is entered and maintained in the safety database system in collaboration with the Medical/Safety business unit.
Ensure Pharmacovigilance files for assigned projects are properly maintained and/or provided to Records Management in a timely manner.
Manage communications between appropriate team members, Clients, and Sponsors when safety issues are identified.
Participate in training sessions and workshops, including presenting reports from any conferences attended, as agreed.
Monitor compliance metrics, project budgets, and service level agreements for assigned projects to ensure regulations and timelines are being met and activities performed are within the approved budget.

**While at Clinigen, you’ll enjoy:**
**The Culture. **Thanks to our diverse opportunities for engagement and involvement, every colleague’s Clinigen experience can be a bit different, and we’re proud of that. We work hard to ensure our company culture is inclusive to people from all backgrounds and social styles.
**The Transparency with Leadership. **All colleagues can share anonymous feedback with leadership on a weekly basis through our employee engagement platform. We use this feedback to inform our actions and decisions. We’ve been able to take steps to continuously improve how we do things at Clinigen.
**The Benefits.** We take pride in having a broad range of activities, systems, and programs that provide a competitive benefit offering and build a culture of celebrating success.
**EEO.** Clinigen is an Equal Opportunity Employer and is committed to providing equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other characteristic protected by applicable law.