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Product Safety Specialist (Pharmacovigilance) - Remote

Job Type
Location
Nutley, New Jersey
Salary
US$45 - US$50 per hour
Job Ref
BBBH2304806_1711466513
Date Added
March 26th, 2024

SRG, the leader in the Life Sciences human capital industry, is looking for a full-time Product Safety Specialist located remotely in the US.

 

The Product Safety Specialist is responsible for receipt and documentation of safety information for Marketed and Investigational Products. Interacts with health professionals and consumers to obtain and follow-up reports of possible adverse events with company products. Provides product information to health care professionals, and consumers. Codes and enters information into the global safety database. Verifies the accuracy, completeness and validity of information for each adverse event report for which he/she is responsible. Assures consistency of case records and documentation.

 

JOB RESPONSIBILITIES include, but are not limited to:

 

  • Accurate and timely data entry of both domestic and foreign adverse event information into the PSSS (Product Safety Surveillance System) consistent with the ARISg coding manual, SOPs/WIDs, process flows and established time frames within the ARISg workflow. Full understanding of the products' Company Core Data sheet, PI, and/or IB for accurate labeling and listedness. Perform appropriate and timely follow-up per department guidelines, including accurate and thorough communication documentation within the case. Maintain proficiency in the utilization of the PSSS, including MedDRA coding. 65%
  • Ensure accurate and timely submissions to regulators, co-marketing partners and affiliates within company and regulatory timeframes. Utilize ARISg for reporting and confirmation of successful distribution and acknowledgement. 15%

     

  • Maintain sufficient knowledge of all company products to ensure professional and knowledgeable discussions with consumers and healthcare providers and dissemination of accurate product information in response to queries. Provide high level customer service to consumers, health care professionals and internal customers. 10%

     

  • Complete all required training within the timelines provided so as to ensure knowledge of all relevant corporate and departmental SOP's, SWP's and WID's. 10%
    Ensure timeliness in regulatory compliance

     

  • Gather sufficient information to assess the medical significance of an adverse event report, while at the same time assuring the information provided adequately addresses the concerns of the health care provider and/or consumer.

WHAT YOU NEED TO HAVE:

 

  • Bachelor's degree
  • Health-care professional
  • Minimum 2-4 years of clinical experience with minimum of 1 successful year in pharmaceutical drug safety
  • Ability to apply clinical medicine to patient care
  • Proficient with medical terminology and standards of patient care
  • Computer proficiency
  • Will not be assigned to toll free phone lines but will function as "case owner" and have full responsibility of

 

** "SRG values your application, our team will be in touch to schedule interviews with candidates moving forward in the process."

 

 

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

Please contact HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.

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