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14 days old

Technical Analyst

Kelly Services
Parsippany, NJ 07054
- Core member of the safety team and is responsible for performing pharmacovigilance activities within the North America PhV unit, in partnership with the Pharmacovigilance Associates II and III and Pharmacovigilance Managers/Director to receive and review adverse event information for pre and post- marketed products.

- Should serve as a liaison with other business units and function as a resource to the team.

Responsible for processing expense reports, purchase requisitions and invoices


Case Intake, Review, Triage, Date Entry, Reportability Assessment & E2B transmission:

- Responsible for triaging of adverse event information , including extraction, upload and triage of XMLs

- Responsible for routing and logging live phone calls from patients to DSA in a timely manner

- Perform daily, weekly, and/or monthly reconciliations of adverse event reports with identified partners and programs as required by Pharmacovigilance Agreements, as well as source documents received from other internal departments where required

- Responsible for receiving and reviewing negative acknowledgments during the time of FDA/Health Canada distribution

- Participate in the US/Canada Pharmacovigilance audits and inspections as needed

- Monitoring of the US/Canada drug safety mailbox

- Receipt of all incoming postal mail and faxes in the US/Canada Pharmacovigilance office


- Responsible for the printing and editing of outbound follow-letters to patients and health care providers

- Provides guidance and training for team members with junior staff; typically acts as a lead, coordinating the work of others with less experience on team

- Responsible for the extraction, upload, and receipt of XMLs

- Works autonomously within established procedures and practices

- Must be well spoken, organized, possess critical thinking and judgment, able to perform well under pressure, and able to represent the job description activities and procedures in interviews with auditors and health authority inspectors


Pharmacovigilance QMS:

- Participate in Pharmacovigilance audits and inspections as needed

- Assist in updating and revising SOPs/WIs whenever processes and procedures are changed to comply with new regulations or to improve procedures of make them more efficient

- Train all the new hires in PhV on systems and processes relating to pharmacovigilance activities and present information/ training in Face-to-Face settings.

- Responsible to complete all training and SOP/WI reviews in a timely manner

Administration

- Responsible for periodic updates to the Krono's system

- Maintains the department filing system in coordination with the overall company records management program

- Process expense reports as appropriate

- Process purchase requisitions and invoices for accuracy and payment as well as setting up PO accounts as needed


PhV Reconciliation:

- Perform daily, weekly, and/or monthly reconciliations of adverse event reports with identified partners and programs as required by Pharmacovigilance Agreements, as well as source documents received from other internal departments where required

Other tasks as assigned by management:

- Other essential duties include drafting pharmacovigilance agendas and meeting minutes, accurately archiving pharmacovigilance documents

- Other tasks as assigned by management

Required: Bachelors of Science (Physics, Chemistry, Biology, Biochemistry, microbiology, physiology, anatomy, pharmacology) Preferred: Rph or RN or Degree in the field of Medicine or Pharmacy or Nursing or equivalent combination of education and related work experience.


Experience:

- Identify the minimum years of experience that would be required / preferred for a candidate to enter this position


Required: 1-2 years of Health Care or Pharmaceutical industry experience

Preferred: 1 year Pharmaceutical industry experience


Demonstrates proficiency with Microsoft Office Word, Excel, PowerPoint and Adobe Acrobat. Knowledge of PhV IT systems such as Arisg, Argus, Cognos is an added advantage

Functional Knowledge:

Comfort with PHV IT systems and a familiarity with the ARISg safety database and medical terminology.

Company / Industry Related Knowledge:

Knowledge of the related FDA/Health Canada and international regulations



**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-02-10 Expires: 2021-03-13

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Technical Analyst

Kelly Services
Parsippany, NJ 07054

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