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Back To Current Job Listings: PHARMACOVIGILANCE REGULATORY ASSOCIATE
PHARMACOVIGILANCE REGULATORY ASSOCIATE
[Dec 03, 2018]

TITLE:                       PHARMACOVIGILANCE REGULATORY ASSOCIATE 

                 

REPORTS TO:           Director, Regulatory Affairs

 

DEPARTMENT:        Scientific Affairs

 

LOCATION:               Berlin, CT

 

TRAVEL:                    N/A

 

JOB SUMMARY:

 

This position reports to Director, Regulatory Affairs and will support the management of Regulatory, Health Care Professional and Customer communications relating to the distribution of Company products in the marketplace as well as ANDA submission support. These activities include Regulatory Compliance activities relating to Pharmacovigilance, processing and reporting ADE’s (Adverse Drug Experiences) to FDA and other regulatory agencies, support to Customer Service in their interaction with health care professionals, customers and patients in response to product information inquiries, and ANDA submission management. 

 

DUTIES AND RESPONSIBILITIES:

 

·         Participate in day to day activities concerning adverse drug experience reports received from the market place, including proper communication for the resolution of these complaints. This activity includes evaluation of these complaints and reporting to FDA MedWatch/ ICSR Program when health care professionals or patients report an Adverse Event in the use of Company product.

 

·         Receive and review adverse drug experience reports from medical literature, present to the Pharmacovigilance Team for evaluation, and submit reportable events through the FDA ICSR Program.

 

·         Manage and assist Sales and Customer Service departments in responding to product inquiries received from the marketplace, e.g., customers, health care professionals and patients.

 

·         Review and complete various portions of new product registrations, relating to drug safety information – for example:Texas Medicaid applications, new product registration in Puerto Rico, State Registrations, Medicaid and other Third Party Plans to assure coverage of Company Products.

 

·         Review and complete various product file requirements for new product launches, such as:HDMA form, relating to product characteristics and drug safety, information received from manufacturers regarding the Breckenridge drug product fact forms/specification sheets.

 

·         Manage the Periodic Report schedule and complete periodic reporting as per the required FDA schedule.

 

  • Create, revise and maintain product labeling including, but not limited to, labels, outserts, cartons, and medication guides per FDA regulations/guidance’s and BPI SOPs.  Draft labeling includes MSWord and PDF copies, annotated (side-by-side) labeling as well as working with external sources to create draft printer proofs, as required. 

 

  • Create and populate eCTD backbone in preparation for transmittal through FDA gateway by the Manager/Director.

 

 

ESSENTIAL QUALIFICATIONS, EDUCATION AND EXPERIENCE:

 

·         Pharm. D (, Physician Assistant, APRN, or RN

·         A keen understanding of community pharmacy marketplace a plus

·         Proficiency in MS Office helpful

·         Good communication skills a must.

 

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