The Compliance Specialist I, Pharmacovigilance / Product Surveillance performs the activities related to intake, handling and processing product complaints and adverse drug events at Akorn. The Compliance Specialist I, Pharmacovigilance / Product Surveillance will enter information received in the database within the allotted timeframe and escalate to management any critical issues. The position reports to the Sr Manager, Pharmacovigilance / Product Surveillance.
Includes the following. Other duties may be assigned.
- Receives and evaluates adverse drug experience and/or product complaints on all AKORN products;
- Performs initial and follow up triage with customers to identify quality issues and adverse events.
- Classifies and distributes the cases to Compliance and Safety Specialists for further processing.
- Escalate quality and/or compliance issues to senior management as appropriate.
- Assist during internal and external inspections pertaining to product complaints and adverse drug events.
- Communication of product related information in response to medical/product inquiries received from the professional community, patients and internal colleagues.
- Develop SOPs as needed.
- Represent Pharmacovigilance/Product Surveillance in internal and external committees & bodies.
Company Overview Who we are?
- Associateâ€™s Degree in chemistry, pharmacy or other life sciences
- Experience in the pharmaceutical industry preferred
- Thorough understanding of FDA and ICH regulations and guidelines
- Ability to work under pressure with minimal supervision
- Ability to multi-task in fast paced environment
- Computer literacy, including Microsoft Office and computer applications.
- Excellent interpersonal skills and professionalism.
Aside from being a pharmaceutical industry leader with deep roots in the eye care community, Akorn has proven through the years, to be a company of clear vision. A vision of what it takes to continually develop and evolve in order sustain our mission, which is to improve patientsâ€™ lives through the quality, availability and affordability of our products. Along with developing and manufacturing branded and generic ophthalmics, Akorn manufactures injectable, oral liquid, optic, topical, inhalant, and animal health products. To learn more please visit our website at www.Akorn.com . Why choose us?
Akorn employees are modern day superheroes! That might sound like an exaggeration; however, when you think of it, superheroes help those in need. That is exactly what we do here at Akorn. If you choose to work with us, you are not choosing to work an ordinary job. You are choosing to make an impact in this world. You are choosing to have a career with purpose. If you are seeking a rewarding opportunity where you can make a difference for others, then put on your cape and join the team!!What do we offer?
- Competitive pay
- Growth and development opportunities
- Tuition Reimbursement
- 3 weeks PTO + Personal Days
- 9 company holidays
- 401K match
- Medical, Dental and Vision Benefit Options
- 100% Paid Maternity Leave
- Fast paced, family-oriented work environment
- Wellness Program
- Inclusive and diverse culture
- Adoption Assistance
- Flexible Spending Accounts
Akorn, Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
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