Aerotek Remote Director Pharmacovigilance Compliance in San Francisco, California
Seeking a Director of PV Compliance to assist with the following:
Quality & Compliance Monitoring (internal and external)
Departmental training requirements and compliance wire management
Domestic and International regulatory and quality requirement oversight
Manage KPI's for vendor population
Extensive experience in Safety Operations (and worked closely with Safety Science)
Quality & Compliance monitoring
PV expert with experience in Quality (but not a Quality auditor role)
Will be responsible for liaising with Quality representatives to lead audits
Represent department for gap analysis
- Hands on involvement with training matrices and curricula
Uploading training content into Compliance Wire
Will help facilitate and provide trainings for internal and external populations
Post Marketed needs to trainings (different than clinical)
Monitor compliance for SUSARs and PSURs
Review and provide oversight for KPIs for vendor population
Will research regulatory requirements through Cortelis
An advanced degree such as a, PharmD, RN or BSN is preferred. Equivalent experience may be accepted. A minimum of 10 years experience in drug safety / pharmacovigilance, with at least 6 year’s hands-on experience in adverse event management in clinical trials evaluating investigational products is required. A minimum of 5 years previous management experience may be required. Experience in pharmacovigilance quality and compliance monitoring. Experience in oncology therapeutic area is preferred but not mandatory. Familiarity with medical terminology required. Ability to process data entry accurately. Ability to code and map data accurately. Concise case narrative (medical) writing experience preferred. Ability to prioritize work without much support. Clear effective written and verbal communication skills are essential for effective communication with study sites. Focused and detail oriented. Work effectively as a team member,
promote collaboration. Self-starter and self-accountability.
Amazing begins here. EASi is a leading global services company specializing in engineering and sciences. For more than 35 years, EASi has delivered critical services across a range of industries, including energy and utilities, transportation, heavy equipment, consumer and industrial products, medical devices, pharmaceutical and biotechnology, as well as academic and health care research. By adapting to the constantly evolving needs of our customers, we have built specialized expertise and a multidisciplinary perspective - leveraging cutting-edge technology and processes - to constantly improve and innovate. Through EASi's flexible solutions and consultative approach, customers in engineering and sciences can expect unparalleled quality, increased speed to market and collaborative customer engagement services.
Headquartered in Hanover, Maryland, EASi has 3,700 dedicated employees across North America, Europe and Asia. EASi is an Aerotek company, a leader in the recruiting and staffing industry. Aerotek is an operating company of Allegis Group® Inc., a global leader in talent solutions. To learn more about EASi, visit EASi.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.