Product Safety Specialist
American Cybersystems, Inc.

Job Info

---

Innova Solutions is immediately hiring for a Product Safety Specialist.

Position : Type: Full Time, Contract on W2.
Duration : 12+ Months
Location: Remote Opportunity

As a Product Safety Specialist, your responsibilities::

Job Description:

• 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.

1. 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%
2. 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%
3. 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%
4. 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
5. 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.

• Healthcare professional required.
• US license not required.
• Minimum of bachelor's degree in healthcare field.
• 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
• Application of clinical medicine to patient care
• Medical terminology and standards of patient care
• Computer proficiency

IMPORTANT:
1) Bachelor's degree
2) Healthcare professional
2) Minimum 2-4 years of clinical experience with minimum of 1 successful year in pharmaceutical drug safety
3) Ability to apply clinical medicine to patient care
4) Proficient with medical terminology and standards of patient care
5) Computer proficiency
6) 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
7) Pursuing follow up information as needed and sending appropriate documents to consumers/HCP's

Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.

Thank you!
Ramesh Tummala - Lead Recruitment
ramesh.tummala@innovasolutions.com
(+1) 678-648-7395

PAY RANGE AND BENEFITS:
Pay Range*: Between $30.00 to $32.50feisai Per Hour
*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.

Recent Recognitions:
One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)
ClearlyRated® Client Diamond Award Winner (2020)
One of the Largest Certified MBE Companies in the NMSDC Network (2022)
Advanced Tier Services partner with AWS and Gold with MS

Website: https://www.innovasolutions.com/

Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.

The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.

---