Director, Pharmacovigilance Operation

Employer
Grifols
Location
Los Angeles, CA, United States
Posted
Nov 19, 2020
Ref
162972
Required Education
Bachelors Degree
Position Type
Full time
Job Summary:

The Director is responsible for direct leadership over Grifols Biological Inc.'s (GBI) pharmacovigilance and (PV) operations. Manages adverse event investigations reported with BIG products reported in the US as well as other countries where the products are licensed. Manages PV compliance audits from domestic and foreign regulatory agencies. Generates periodic safety update reports, annual safety reports and risk management plans as needed for relevant territories.

Essential Job Duties:

  • Manage and process all adverse events (AE) reported with GBI products in the US and other countries where the products are licensed.
  • Investigate all adverse events reported with BIG products and is a liaison between GBI and Global PV.
  • Represent company at FDA Good Manufacturing Practice audits and other regulatory agency audits of PV procedures.
  • Manage AE investigations for the US and other countries where Grifols products are licensed.
    Prepare PV regulatory reports such as FDA's MedWatch reports, annual safety reports (e.g. PSURs, PSRs).
  • Develop and update Standard Operating Procedures for processing AEs as necessary.
  • Oversee AE trending reports and PV data analysis.
  • Medical liaison with other company departments including quality, legal, regulatory and manufacturing.
  • Triage all product complaints and forward the complaint to the appropriate team members.
  • Provide scientific and/or technical advice and counsel regarding projects as needed.
  • Maintain current knowledge of regulatory and industry standards, trends and advancements through independent reading and training. Generate periodic safety update reports, annual safety reports and risk management plans as necessary.


Job Requirements:

  • Minimum of Bachelor's degree in Life Sciences or related field is required
  • Minimum of 5 years' experience in Pharmacovigilance is required
  • Previous regulatory audit experience is preferred.
  • Excellent problem solving and decision making skills, with demonstrate ability to use good judgment.
  • Good organizational skills with ability to perform multiple priorities efficiently and effectively. Knowledgeable of Pharmacovigilance FDA, EMEA, ICH, GMP, GCP guidelines.
  • Demonstrated experience with SOP and process creation.
  • Demonstrated leadership skills. Flexibility and adaptability.
  • Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner. Motivated self-starter, with ability to maintain a positive attitude.

Demonstrated knowledge of applicable computer systems and applications such as Word, Excel etc.

*This job description is accurate at the date of publication . It is intended to provide information essential to understanding the scope and general nature of the work performed by job holders within this position. This job description is not intended to be an exhaustive list of qualifications, skills, duties, responsibilities or working conditions associated with the position. Other duties may be assigned and qualifications required may change over time.

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.