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20 days old

Pharmacovigilance Specialist II/Drug Safety Associate/Drug Safety Office

Kelly Services
Parsippany, NJ 07054
**Kelly Services** has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a contract temporary opportunity to work as **Pharmacovigilance Specialist II/Drug Safety Associate (2 positions)** at a prestigious Fortune 500 company working in **Parsippany, NJ.**



**Length: 3 months**



**rate: $30/hour**



**Description:**



**Pharmacy Tech experience preferred, Generic brand knowledge, Good Communication skills**


**Position Summary: Pharmacovigilance Specialist II/Drug Safety Associate/Drug Safety Officer**

- 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 Teva 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 acknowledments during the time of FDA/Health Canada distribution

- Participate in the US/Cananda 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 kronos 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:**

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


**Additional Requirements:**

Ability to develop cooperative working relationships with all levels of staff is critical

Quality traits of diplomacy, professionalism, tact, and arbitration are important

Must be a team player; possess excellent communication skills with a high degree of overall poise, tact and courtesy; must be detail oriented and be willing to work in a hectic paced environment with time-sensitive materials

Ability to develop cooperative working relationships with all levels of staff is critical



**Apply Now!**



This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must submit your resumes. Thank you for your interest in the assignment.



**Also, feel free to follow up via email to RACS113@KELLYSERVICES.COM**




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



As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.




**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.

\#KellyGTS

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Posted: 2020-05-08 Expires: 2020-06-11

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Pharmacovigilance Specialist II/Drug Safety Associate/Drug Safety Office

Kelly Services
Parsippany, NJ 07054

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