Job Description

At NS Pharma we believe in the potential of new therapies, such as our exon-skipping technology for Duchenne muscular dystrophy, to redefine the way patients and healthcare providers fight rare diseases. We take pride in our drive for future innovation and commitment to helping patients live healthier, happier lives. 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. Responsibilities: 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 Preferred 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

Job Tags

2 days per week,

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