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Product Quality Assurance Specialist
3 months ago
For over two decades, ProPharma has enhanced patient health and wellness by delivering insights and expertise that empower biotechnology, medical device, and pharmaceutical organizations of all sizes to confidently advance scientific innovations and launch new therapies. As the largest Research Consulting Organization (RCO) globally, ProPharma collaborates with clients through an advise-build-operate model throughout the entire product lifecycle. With extensive knowledge in regulatory sciences, clinical research solutions, quality and compliance, pharmacovigilance, medical information, and R&D technology, ProPharma provides a comprehensive suite of customizable consulting solutions that mitigate risks and expedite our partners' most significant drug and device initiatives.
This role of Product Complaint Specialist is vital in assessing Product Complaint cases generated by Medical Information for subsequent actions. The Specialist may facilitate product retrievals, conduct follow-up communications regarding product complaints, generate related correspondence, and perform additional product complaint services for designated clients. Furthermore, the Specialist may prepare and review reconciliation reports as required by clients. This position demands an individual with exceptional technical skills for proofreading and managing various processes and timelines within a regulated environment.
Key Responsibilities Include:
* Review product complaint cases to determine necessary next actions (if applicable):
* Coordinate retrievals for specific client companies, if applicable
* Conduct outbound follow-up calls to finalize Product Complaint reports and gather additional information as requested by the client.
* Draft letters in response to Product Complaints as instructed by the client.
* Provide additional contracted product complaint services for selected client companies.
* Enter electronic correspondence cases
* Generate and execute reconciliation reports as needed.
* The Product Complaint Specialist will confidently identify any new or follow-up Adverse Event details and report them to the appropriate contacts.
* The Specialist will also confidently identify any new or follow-up Product Complaint details and report them accordingly.
* Offer administrative support for Medical Information as required.
* Manage the Product Complaint inbox.
* Update existing Product Complaint cases as necessary.
* Respond to inbound calls and check voicemails for the Product Complaint line.
* Other duties as assigned.
Qualified candidates should possess:
* Pharmacy Technician, Veterinary Technician, Life Science Graduate, or other healthcare-related equivalent preferred.
* High School Diploma.
* Excellent English language skills, particularly in verbal and written communication (including proofreading).
* Ability to write fluent and grammatically correct American English.
* Familiarity with medical terminology, regulations, and industry standards.
* Exceptional interpersonal skills, including empathetic customer service abilities.
* Accurate and proficient data entry skills.
* Capability to multitask with attention to detail within strict timeframes.
* Proactive approach with a demonstrated ability to independently identify issues and propose effective solutions.
* Ability to organize and prioritize tasks in a rapidly changing environment with resource constraints.
* Willingness to take direction and learn.
* Openness to constructive feedback.
* Self-motivated with an ability to demonstrate initiative and internal drive. Eagerness to seek additional workload projects.
* Ability to work effectively both independently and as part of a team.
* Highly proficient in computer applications, including Microsoft Office software and Adobe Acrobat, with experience using a document management system. Ability to learn other computer systems, including inquiry handling databases.
We celebrate our differences and strive to create a workplace where each individual can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
