1 Global PV & Drug Safety Associate Job in Ann Arbor, MI

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Global PV & Drug Safety Associate

ESPERION THERAPEUTICS INC

Ann Arbor, MI | Full Time

$78k-103k (estimate)

2 Months Ago

Global PV & Drug Safety Associate

$78k-103k (estimate)

Full Time 2 Months Ago

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ESPERION THERAPEUTICS INC is Hiring a Remote Global PV & Drug Safety Associate

Company Overview

Our Mission: At Esperion, we are working tirelessly to deliver innovative medicines that help patients reach their goals today, tomorrow, and into the future.

Esperion is a fully remote based company with a corporate headquarters located in Ann Arbor, MI. The Company offers a competitive salary including a performance-based bonus program and stock-based compensation, a comprehensive benefits package including a 401(k) matching plan and health insurance, and paid time off and holidays.

Position Title: Global PV & Drug Safety Associate

Preferred Location: Remote – US

Essential Duties and Responsibilities*

Assist PV Director and Senior Manager with oversight of outsourced activities within Global Drug Safety and Pharmacovigilance. This includes SAE management and safety database management in accordance with applicable regulatory guidelines/ regulations and study procedures.
- Assist PV Director and Senior Manager with weekly/monthly reconciliation as necessary.
- Assist PV Director with Adverse Event Reporting training to employees, vendors and contractors as needed.
- Perform monthly End of Line Quality Control (EOLQC) for oversight of vendor processed cases. Includes review of SAE reports to ensure accuracy, integrity and completeness of safety information and to ensure consistency of medical coding of safety data.
- Support Global Drug Safety and Pharmacovigilance during regulatory inspections and audits.
- Maintain current knowledge of global adverse event reporting obligations; assist with maintenance and update of Esperion policies and procedures as needed to comply with new or updated global regulations.
- Assist with developing, maintaining and tracking corrective and preventive actions (CAPAs) as necessary.
- Maintain current knowledge global regulatory pharmacovigilance landscape.
- Able to work in an environment of rapidly changing priorities and has the ability to manage multiple projects/issues.
- Support with aggregate report activities and support signal management process to include IND, NDA Annual Reports (DSUR, PSUR, Periodic Reports, etc.)
- Assist with PADER line listing review to ensure accuracy, integrity, and completeness of safety information.

additional duties and responsibilities as assigned

Qualifications (Education & Experience)

Degree in medically related field required with nursing or pharmacy background being strongly advantageous.
5 years industry experience in the health, clinical, bio-pharmaceutical, or relevant industries such as, pharmacy or nursing is preferred.
Basic understanding of medical and drug terminology preferred.
Competence in MS Office (Word, Excel, PowerPoint).
Experience with SharePoint usage or similar systems.
Understanding of global regulatory requirements for clinical trial conduct and governing regulations.
Ability to gain knowledge quickly about FDA, EU, ICH guidelines, initiatives and regulations governing both safety reporting and processing for both clinical trial and post marketing environments.