Associate Director / Director, Drug Safety

Job Description

Job Title:

Department:

Medical Affairs and Pharmacovigilance

Location:

Paramus, NJ/Hybrid

Reports To:

VP, Medical Affairs

Status:

Regular, Full-time, Exempt

Start Date:

Compensation:

Job Summary

This position oversees the outsourced Drug Safety and Medical Information Call Center activities for NS Pharma. This position is responsible for the review of all US spontaneous safety reports and global Clinical Trial safety reports, as well as the review of various regulatory documents such as the PADER, NDA Annual Report and the PBRER. In addition, a review of global regulatory submission documents is conducted as needed. This person will also have oversight of the Medical Information Call Center to respond to escalated questions and draft response letters as needed.

Essential Duties and Responsibilities
(Include but not limited to the following. Other duties may be assigned.)

Oversee the outsourced Drug Safety and Medical Information Call Center Activities
Review all US spontaneous safety reports for accuracy, completeness and determination of the validity of the case
Review and edit as needed the narratives for US spontaneous safety reports
Review Clinical Trial safety reports for accuracy and completeness
Review regulatory reports (PADERs, PBRERs, NDA Annual reports)
Respond to escalated questions from the Call Center

Qualifications

Experience in pharmaceutical drug safety & safety design approach
Knowledge of the FDA reporting obligations of spontaneous adverse event reporting
Knowledge of clinical trial safety reporting
Patient Safety and/or Clinical/Drug Development with proven experience working in safety &/or scientific activities Clinical drug development (Early and/or Late Phase: develop & deliver program level safety strategy, including proactive risk identification & mitigation planning)
Safety governance board interactions and communication across a range of activities
Demonstrated ability to handle more than one activity simultaneously, prioritizing and recognizing key issues
Ability to work effectively in a matrix structure
Good writing, organizational and communication skills

Education and/or Experience

PharmD, MD or other allied health professional experience required
7-10 years of experience within the field of medical affairs or related areas
Minimum 5 years of experience in a pharmaceutical drug safety department
Experience with a diverse number of therapeutic areas, preferably in rare disease
Must reside within a reasonable commuting distance to Paramus NJ as employees are required to work in-office on a hybrid basis (2 days in the office).
This is a Hybrid position that requires employees to be in the office two days a week in Paramus