Pharmacovigilance Case Manager

Location: 

CA-Los Angeles, US

Contract Type:  Regular Full-Time
Area:  Pharmacovigilance
Req Id:  424368

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

Summary :

Primary responsibility is to manage the workflow and processing of individual case safety reports (ICSRs) and assure all documents are processed in compliance with regulatory requirements.  Assess adverse event (AE) cases to develop a scientific company causality assessment for review. Will identify issues when needed regarding individual case report processing as well as database data entry within the Drug Safety department and utilize knowledge and expertise to find appropriate resolutions.  Incumbent is a vital communication link between the Data Safety Coordinators, Scientist and Management, along with performing the daily activities related to the scrutiny, collection, analysis, and review of safety documents for marketed and investigational new drug products.  Will classify events according to reporting requirements being able to perform complicated medical coding of AE terms, create clear, concise and medically relevant report narratives, regulatory reports, perform follow up request and review of information for further review and completeness.

 

Primary Responsibilities:

●Works as a case manager ensuring that all aspect of an ICSRs are performed within regulations and SOPs.

 

●Collect and process AE information to finalize cases and prepare for regulatory submission.

 

●Responsible for identifying and resolving errors, problems, omissions or inconsistencies within case reporting.

 

●Ensures the development of line-listing reports, aggregate and periodic reports for both post marketing and clinical trials, 15-Day Alert Reports and IND Safety Reports.  Ensures quality control of data.

 

●Communicates with reporters, physicians and study personnel in an effort to develop scientific case assessments.

 

●Establish and maintain relationships with Grifols' external contributors and study personnel.

 

●Provide to management follow up regulatory (external) requested reports, Periodic Safety, Update Report (PSUR), etc.

 

●Represents the department and Grifols through attending internal/external meetings, forums, seminars to include Global, interdepartmental, clinical and investigator.

 

●Conduct training to external vendors and internal groups including Sales/Marketing, Regulatory Affairs and individuals involved in the post marketing drug safety surveillance.

 

Requirements:

Skills: Profound usage and understanding of medical terminology is essential.  Knowledge of FDA and ICH principles of SAE/AE reporting along with proficient understanding of regulatory roles and regulations locally as well as globally is important.  Accomplished and expert knowledge of the coding techniques required for AEs using terminology prescribed by global regulatory authorities is crucial.


Diversified knowledge, including knowledge of safety policies and procedures, along with FDA and ICH regulations is vital.  Must have strong abilities for organization and follow-through. Excellent oral and written communication skills are essential. The ability to develop cooperative working relationships with all levels of staff is critical. Quality traits of diplomacy, professionalism, tact, and arbitration are important to this position.
 
Must poses advanced computer proficiency and reporting skills and strong knowledge of a global safety database.

 

Education: Required Bachelor's degree in Health Sciences, nursing, Pharmacy, or degree in field of physician assistant.

 

Experience: 8 plus years of drug surveillance, clinical departments and in a similar clinical setting is preferred.

 

Equivalency: Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.  Example:  If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

*This job description is accurate at the date of publication and may change over time.  It is not intended as an exhaustive description of the job.  Other duties may be assigned and qualifications required may change.

 

 

EEO Minorities/Females/Disability/Veterans

 

 

Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws.  We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

 

Location: NORTH AMERICA : USA : CA-Los Angeles || NORTH AMERICA : USA : NC-Clayton:USVALLEY - Valley - Valley Blvd - LA, CA 

 

Learn more about Grifols

 


Nearest Major Market: Los Angeles