Division Overview:

Eugia’s mission is to make the process of buying specialty pharmaceutical products an experience customers look forward to, and our vision is to become synonymous with excellent customer service and continuously improve upon this excellence by being transparent, responsive, and consistent. We are expanding Eugia’s capabilities to include the manufacture of highly complex injectables to answer that need.

Job Overview:
Responsibilities:

• Handling product complaints: initiating/receiving, processing and closing as per applicable standard operating procedures (SOP)
• Prepare complaint samples for shipment to manufacturing unit for investigation
• Interacting/doing follow-up with the customer/reporter on a daily basis to acquire information that may be required to effectively investigate a product complaint
• Reviewing the final investigations received from the manufacturing units to ensure accuracy.
• Following up with Corrective Action/ Preventative Action plans to ensure technical issues are being addressed
• Provides information needed for status of recall, quarantines, and product returns to the recalling manufacturer.
• Responds to inquiries made by management to resolve customer needs or concerns, including recall instructions, product listing information, and product returns and credit information
• Collaborates with internal stakeholders, including Procurement, Category Management, and Customer Service teams as required
• Supports Center operations with periodic FDA and internal audits
• To assist in appropriately handling initial receipt of ADE and processing it as per applicable SOPs
• As deemed necessary, to assist in the handling and processing of field alert reports to FDA
• Completing the monthly Compliance Reports for Recalls and ADE's and submitting them to Global PVG in a timely manner
• Responsible to prepare, update, maintain and compliance of the In-house SOPs, Quality System & Policy.

Qualifications - Skills & Requirements:

• Must be cordial and responsible while talking to customers, complainants or other associates
• Must be very organized and possess high standard work ethics
• Effective communication, attentive listening is a must.
• Skill to record the information received promptly and correctly on the appropriate documentation form is a must
• Must have an experience to represent and support during FDA Inspection
• Must be cooperative when assigned other responsibilities
• Must be proficient in using Excel and Word

Education & Experience:

• Minimum of Bachelor of Science or equivalent professional experience.
• PharmD or Master’s degree (in Science / Pharmacy) is preferred but not required
• 3 to 5 years of experience working in Quality / Pharmacovigilance or related role in Healthcare industry

Physical Requirements: OFFICE POSITION - While performing the duties of this job the employee is required to: •Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment •Specific vision abilities required by this job include close vision requirements due to computer work •Light to moderate lifting is required •Moderate noise (i.e. business office with computers, phone, and printers, light traffic). •Ability to sit at a computer terminal for an extended period of time Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met. Additional Physical Requirements: No Additional Requirements Blood/Fluid Exposure Risk: Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.