Product Safety Specialist - Remote - Start Immediately

Product Safety Specialist needed for a remote contract opportunity with Yoh Scientific’s client located in Nutley, NJ.
 
Schedule: 100% remote, Monday through Friday, 7.5 hours a day
 
This position is for a major pharmaceutical company, and they are looking for someone with a bachelor’s degree in the healthcare field, with minimum 2 to 4 years in industry application of clinical medicine/pharmacy with a minimum of 1 year in pharmaceutical drug safety. Experience in verbally interviewing and/or providing medical information to health care professionals and consumers is a plus.
 
Responsibilities

• 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 Eisai 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.
• 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 Eisai 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 to ensure knowledge of all relevant corporate and departmental SOPs, SWPs and WIDs. 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.

 
Qualifications

• Bachelor's degree
• Healthcare 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 adverse event report management from beginning to end
• Pursuing follow up information as needed and sending appropriate documents to consumers/HCP's

 
Opportunity is Calling, Apply Now!
 
Contract: 12 months with potential for extension and/or conversion
Salary: $38 - $46 per hour depending on experience, W2
Recruiter: Ery Baniqued
 
What’s In It for You?
We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you.
 

• Medical, Dental & Vision Benefits
• 401K Retirement Saving Plan
• Life & Disability Insurance
• Direct Deposit & weekly ePayroll
• Employee Discount Programs
• Referral Bonus Programs

 
Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more here!

Note: Any pay ranges displayed are estimations.  Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description.  All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.