Product Safety Specialist needed for a one year W2 contract for a Global Pharmaceutical Company in Nutley, NJ. This role is REMOTE.
The Product Safety Specialist will manage safety information for Marketed and Investigational Products, interacting with healthcare professionals and consumers to collect adverse event reports. Provide product information, code and input data into the global safety database, and ensure accuracy and consistency in documentation. **
What you can bring to this role:**
- Bachelors Degree in the healthcare field
- Must be a health professional. US license is not required
- 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
The day to day:
- 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 so as 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.
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
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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.
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.
