Why Us?
At Par Health, we believe great healthcare is built on getting the essentials right. We’re looking for passionate, talented individuals who share our commitment to improving lives. With a global workforce, we lead with pride and purpose—prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn’t just our tagline, it’s the higher standard we live by every day.
Job Description Summary
The Principal Product Surveillance Specialist is primarily responsible for monitoring the safety, quality and efficacy of products marketed and sold by Par Health (“The Company”). This is accomplished by receiving, capturing and evaluating product feedback reports from the field in accordance with current FDA and global regulations and guidelines. Additionally, they provide technical and clinical information regarding product usage and performance. This role will provide global Quality oversight for field alert reports, health hazard evaluations, and the recall process. As a result of these activities, they will frequently develop, preserve and strengthen customer relationships which is a necessary and expected commodity in today's competitive pharmaceutical, biologic, and medical device industries. Also, establish and maintain positive and mutually rewarding relationships with internal customers.Job Description
ESSENTIAL FUNCTIONS:
1. Global Quality oversight and review of field alert reports.
2. Initiation and coordination of the Health Hazard Evaluation process.
3. Coordination of field actions and the mock recall process.
4. Answer and triage incoming calls via the automatic call distribution line.
5. Review and approve customer complaint response letters.
6. Capture, review and analyze customer usage reports.
7. Follow up on post-market customer usage and field service reports as necessary.
8. Evaluate complaints for potential adverse events which are then forwarded to pharmacovigilance.
9. Collaborate with colleagues globally on reports that are received from outside the US.
10. Conduct trend analyses in order to provide and alert to changing safety and efficacy profiles on regular and ad-hoc basis.
11. Prepare and deliver accurate reports of continuing product performance for Quality and other departments of The Company.
12. Identify potential product performance issues and alert appropriate management personnel when needed.
13. Initiate and coordinate investigations for complaints and support medical inquiries.
14. Comply with relevant global product quality related guidelines, standards and regulations regarding the receipt, review, investigation, and reporting of product usage experiences.
15. Provide oversight of customer usage experiences, field feedback reports, product safety reporting, and professional consultation in matters related to safety, efficacy, and proper product functioning.
16. Work in conjunction and effectively communicate with various departments, including Legal, Regulatory Affairs, R&D, Commercial, Pharmacovigiliance, Medical Information, Customer Service, and the Manufacturing Sites.
17. Provide clinical and technical support of marketed pharmaceutical products as needed.
18. Provide product performance expertise on cross-functional project teams as necessary.
19. Participate in teams concerned with development or support of products as necessary.
20. Provide support during Audits and Regulatory Inspections.
21. Lead process improvement initiatives.
22. Provide training for new hires, site personnel, and sales representatives regarding Post Market Reporting Practices as necessary.
MINIMUM REQUIREMENTS:
Education:
Bachelor's degree in chemistry, chemical engineering, or a related science or clinical
Experience:
1. A minimum of eight years Quality experience in a pharmaceutical manufacturing environment.
2. Previous Post-Market Surveillance, health hazard evaluation, or field alert report experience in the pharmaceutical and/or medical device industry is preferred
Preferred Skills/Qualifications:
1. Knowledge of FDA regulations and guidances in the area of complaint handling for pharmaceuticals, biologics, or medical devices.
2. Experience interacting with regulatory agencies such as the FDA.
3. Writing skills necessary to effectively communicate technical/clinical information to others.
4. Comfortable and capable of using software programs (Word, Excel, Power Point, Access) and a willingness to expand and increase these competencies.
5. Excellent verbal and written communication skills including excellent telephone etiquette. Must be comfortable handling discussions with patients and health care providers on health and medical topics.
Skills/Competencies:
1. Committed, self-motivated team player
2. Problem solving and analytical skills.
3. An ability to effectively integrate customer and business needs in a satisfactory manner.
Other Skills/Competencies:
1. Sound organizational skills with the ability to prioritize tasks.
2. Ability to build productive relationships with personnel within and outside of the department and company.
3. Ability to work effectively in multi-functional teams.
ORGANIZATIONAL RELATIONSHIPS/SCOPE:
· Reports to Manager, Product Monitoring
· Frequent communication and working relationships with customers, manufacturing QA personnel, and Medical Information Specialists
· Interact with a variety of Corporate Divisions. These include, but are not limited to, Legal, Regulatory Affairs, Medical Information, Pharmacovigilance, R&D, Marketing, Quality Assurance, Sales, and Customer Service. The degree and scope will vary according to the needs of the departments involved
WORKING CONDITIONS:
· Normal office conditions, which include sitting for long periods of time and computer and phone use.
· Occasional travel may be required for such things as training seminars, manufacturing site visits, and professional/trade conventions.
· Hybrid working schedule
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
EEO Statement:
We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Skills Required
- Bachelor's degree in chemistry, chemical engineering, a related science, or a clinical field
- At least eight years of quality experience in a pharmaceutical manufacturing environment
- Knowledge of FDA regulations and guidance for complaint handling involving pharmaceuticals, biologics, or medical devices
- Experience interacting with regulatory agencies such as the FDA
- Strong technical and clinical writing skills
- Proficiency with Microsoft Word, Excel, PowerPoint, and Access
- Excellent verbal and written communication skills and telephone etiquette
- Ability to discuss health and medical topics with patients and healthcare providers
- Post-market surveillance, health hazard evaluation, or field alert report experience in the pharmaceutical or medical device industry
Endo Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Endo and has not been reviewed or approved by Endo.
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Fair & Transparent Compensation — Pay is considered competitive to good across many roles, with total compensation in commercial positions strengthened by sizable bonus/OTE when targets are met. Subsidiary experiences within the group also point to good compensation, reinforcing a generally positive pay story.
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Healthcare Strength — Core medical, dental, and vision coverage is strong, complemented by virtual care, disease‑management programs, and a health advocate service. Health coverage is described as good, adding perceived value beyond base pay.
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Retirement Support — A 401(k) plan provides a company match up to 4%, supporting employees’ long‑term savings. Current materials outline the matching formula clearly for prospective comparisons.
Endo Insights
What We Do
At Endo, our far-reaching vision is simple: to help everyone we serve live their best life. As a specialty pharmaceutical company, we’re motivated by a strong sense of purpose to find better ways to meet unique medical needs. Our global team of passionate employees understands the importance of their work. We’re dedicated to supporting one another as we connect with communities and foster partnerships that elevate quality-of-life and bring the best treatments forward. Our uncompromising commitment results in the delivery of life-enhancing therapies. From intelligent product selection to commercialization, we strive to make a meaningful, tangible impact to help everyone live their best life. Endo has global headquarters in Malvern, Pennsylvania. Community Guidelines: 1. Be respectful. Everyone who visits our page should feel comfortable and respected. 2. If we see a comment that violates anything in the following list, it may be removed. • Comments that use profanity; personally attack or bully another individual; or are off-topic, misleading, factually inaccurate, political, spam, defamatory, discriminatory or promotional. • Comments that are excessively repetitive and/or disruptive to the community. • Comments that promote illegal activity, use copyrights or trademarks or are related to an ongoing legal matter. • Comments that appear to be medical advice. We reserve the right to remove a reply for any reason at any time. 3. Adverse Event Reporting: If we see a post about an adverse event, an Endo representative will need to contact you to find out more information to comply with regulatory guidelines. If you experience a side effect while using an Endo product, please consult your physician or pharmacist immediately. You may also report to the FDA at fda.gov/medwatch or 800-FDA-1088. Replies from other users do not necessarily reflect the views of Endo. We do not endorse content added by other users.
