Product Integrity Specialist

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.

This Product Integrity Specialist position is critical in evaluating data for Product Complaints and Adverse Events. The Product Integrity Specialist may create cases, coordinate product retrievals, perform follow-ups via phone, generate follow-up related correspondence and complete additional services for select clients. The Product Integrity Specialist may also prepare, and review, reconciliation reports as needed by clients. This position requires someone with an extreme technical ability for proofreading and keeping a variety of processes and timelines straight within a regulated environment.

Essential Functions:

• Perform case review for Product Complaint (PC) and Adverse Event (AE) cases created by Medical Information to determine next action(s) required (if applicable):

• Coordinate Retrieval for select client companies, if applicable

• Place outbound follow up calls to complete Product.

• Complaint reports and collecting additional information as requested by the client.

• Create letters in response to Product Complaints as directed by the client.

• Additional contracted PC and AE services for select client companies.

• Case entry of electronic correspondence

• Create and run reconciliation reports as needed.

• The Product Integrity Specialist can confidently identify any new or follow-up Adverse Event details and report to appropriate contacts.

• The Product Integrity Specialist can confidently identify any new or follow-up Product Complaint details and report to appropriate contacts.

• Provide administrative support for MI group as needed.

• Manage Product Integrity inbox(es)

• Update existing Product Complaint and Adverse Event cases as appropriate.

• Answer inbound calls and check voicemails.

• Other duties as assigned.

Necessary Skills and Abilities:

• Excellent English language skills especially verbal and written (including proofreading) communication skills.
• Ability to write fluent and grammatically correct American English.
• Working knowledge of medical terminology, regulations, and industry standards.
• Excellent interpersonal skills including empathetic customer service skills.
• Accurate and proficient data entry skills.
• Ability to multi-task with attention to detail within restrictive timeframes.
• Proactive with demonstrative ability to independently identify problems and suggest effective solutions.
• Ability to organize and prioritize in quickly changing environment within resource constraints.
• Ability to take instruction and learn.
• Receptive to constructive feedback.
• Self-motivating. Ability to demonstrate initiative and internal drive. Willingness to seek out additional workload projects.
• Effectively work independently and as part of a team.
• Highly proficient in computer applications, including Microsoft Office software platforms and Adobe Acrobat, and experience using a document management system. Aptitude to learn other computer systems including inquiry handling database.

Educational Requirements:

• Pharmacy Technician, Veterinary Technician, Life Science Grad, or other Healthcare related equivalent required.

Experience Requirements:

• Minimum 1-3 years' previous experience in an administrative or data entry role.
• At least 1-3 years' experience in medical or pharmaceutical industry field especially in Medical/Drug Information, Pharmacovigilance, Product Complaints, and/or Quality Assurance preferred.

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We celebrate our differences and strive to create a workplace where each person 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.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

• ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.*