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.