Sr. Product Surveillance Specialist

Location: Hazelwood

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 4,000+ team members worldwide, 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
** A 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.

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. Establish and maintain positive and mutually rewarding relationships with internal customers.
** Job Description
**** ESSENTIAL FUNCTIONS****:
** Answer and triage incoming calls via the ACD line. Capture, review and analyze customer usage reports. Follow up on post-market customer usage and field service reports as necessary. Evaluate complaints for potential adverse events which are then forwarded to pharmacovigilance. Collaborate with colleagues globally on reports that are received from outside the US. Conduct trend analyses in order to provide and alert to changing safety and efficacy profiles on regular and ad-hoc basis.

Prepare and deliver accurate reports of continuing product performance for Quality and other departments of The Company. Identify potential product performance issues and alert appropriate management personnel when needed. Initiate and coordinate investigations for complaints and support medical inquiries. Comply with relevant global product quality related guidelines, standards and regulations regarding the receipt, review, investigation, and reporting of product usage experiences.

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. Work in conjunction and effectively communicate with various departments, including Legal, Regulatory Affairs, R&D, Commercial, Pharmacovigilance, Medical Information, Customer Service, and the Manufacturing Sites. Provide clinical and technical support of marketed pharmaceutical products as needed.

Provide product performance expertise on cross-functional project teams as necessary. Participate in teams concerned with development or support of products as necessary. Initiation and coordination of the Health Hazard Evaluation process. Support all field actions and coordination of the mock recall process. Provide support during Audits and Regulatory Inspections. Lead process improvement initiatives. Provide training for new hires, site personnel, and sales representatives regarding Post Market Reporting Practices as necessary.
** MINIMUM REQUIREMENTS****:
**
* Education:

* Bachelor's degree in clinical with a healthcare certification required (i.e. RN, RPh, Pharm

D, Physician’s Assistant, Nurse Practitioner, Respiratory Therapist, etc.)

* Experience:

* 1. A minimum of five years clinical/practical experience in a relevant clinical environment required.
2. Previous Quality Assurance or Regulatory Affairs 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 and 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,…