Tonix Pharmaceuticals
Pharmacovigilance Scientist
Berkeley Heights, NJ · Director
No sponsorship$116k-$170kDetected 8 days ago
Data AnalysisProject ManagementExcelProcess ImprovementRecruitingIntellectual PropertyClinical TrialsPharmacovigilanceLeadershipCollaborationPublic SpeakingMicrosoft Office
About the role
- Tonix Pharmaceuticals* is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need.
- TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8 mg) is the first new treatment for fibromyalgia in adults in more than 15 years.
- Tonix is investigating TONMYA® in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction.
Responsibilities
- Perform cumulative safety data reviews across trials or programs to assess safety profiles and identify emerging risks or trends
- Coordinate and document ongoing safety surveillance activities.
- Lead aggregate report (PSUR/PADER/DSUR) activities, including vendor oversight and project management, database requests, data analysis, report authoring, and quality checks
- Manage literature review plan for assigned product(s) and provide feedback to vendor on routine literature surveillance activities
- Perform safety data analyses, draft query responses, and prepare documents for cross functional review and finalization
Requirements
- Other tasks as assigned or required
- Demonstrated ability to prioritize multiple assignments and proactively identify solutions, as needed
Skills
- Scientifically sound and clinically accurate approaches to interpret data involving patient safety.
- Strong knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects), MedDRA, and Argus Safety System
- Pet Insurance
- Retirement Savings 401k with company match and annual discretionary stock options
- Generous Paid Time Off, Sick Time, & Paid Holidays
- Career Development and Training
- Education and Experience Requirements
- Salary Range
- $116,000 - $170,000 USD
- Recruitment & Staffing Agencies
- Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition.
- Compensation & Benefits
Compensation
- $116,000 - $170,000 USD
- Tonix provides a comprehensive compensation and benefits package which includes:
- Retirement Savings 401k with company match and annual discretionary stock options
- This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training.
Benefits
- Coordinate responses for ad hoc safety queries (eg, health authority requests) in collaboration with the cross functional team members, as needed.
- Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs
Equal opportunity
- Tonix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, genetics, or any other characteristic protected by law.
Visa & Work Authorization
- Please note that Tonix does not offer sponsorship for this role.
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This listing is sourced directly from Tonix Pharmaceuticals's careers page and normalized into a canonical job model.