Associate Director, Drug Safety and Pharmacovigilance

About Tonix*

Tonix is a biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP). The Company is focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease. Tonix markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. The Company’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, which also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases.  

Position Overview 

Tonix is looking for a full-time Associate Director, Drug Safety & Pharmacovigilance responsible for supporting all operational functions within the drug safety and pharmacovigilance department. This role provides operational oversight of outsourced Drug Safety activities, taking a leadership role in the management of vendor drug safety deliverables.  The person in this role helps organize and coordinate projects that involve various vendors and cross-functional leads responsible for the collection, processing and collation of adverse event data from post-marketing and clinical trial sources. This position will report directly to the Vice President, Medical Affairs and will be based at the Chatham, NJ office or possibly remote. 

Essential Duties 

• Provide general oversight of vendors involved in drug safety activities
• Assist in safety surveillance/pharmacovigilance activities including responses to regulatory authorities and internal partners
• Review individual case safety reports and aggregate safety data and assist with ad hoc or routine safety monitoring activities and ongoing benefit risk evaluation
• Development of metrics and other tools necessary to assess vendor performance and compliance with regulatory requirements associated with the collection and reporting of safety information from clinical trials
• Work closely with Clinical Operations in the achievement of clinical study milestones involving safety data cleaning, reconciliation and database locks
• Work closely with external Pharmacovigilance vendor and Information Technology on activities related to the oversight of the safety database and associated electronic gateways. Assist with aggregate safety data outputs for periodic reporting and internal safety reviews
• Manages the ongoing development and revisions of departmental documentation such as SOPs, WIs, workflows and guidelines, and ensures compliance with such procedures
• Assist with monitoring workflow to ensure all deadlines are met and participate in the maintenance of Safety Management Plans (SMPs), other safety-specific plans and contractual agreements with business partners as required
• Involved in the development and updating of Drug Safety curricula and training program, which includes general training of Tonix employees, contractors, vendors and business partners on adverse event collection and reporting requirements.  Responsible for oversight of training compliance
• Liaise with Quality Assurance, Medical Affairs, Regulatory Affairs, Marketing, Commercial and other functional areas to facilitate open communication and ensure an accurate understanding of the safety profile of Tonix products
• Contributes to the development of safety management plans, risk management plans, PSUR, PADER, and other aggregate reports as needed
• Supports the preparation of regulatory documents including Investigator Brochures, INDs, NDAs, CCSI, US prescribing information/package inserts and other reports as necessary from a safety perspective
• Plays a key role in business partner relations involving pharmacovigilance activities and the development of safety data exchange agreements, as necessary
• Ensure compliance with internal procedures and regulatory requirements to ensure inspection readiness at all times
• Assist with CAPA/audit or inspection finding investigations and compilation of data to support quality and compliance processes
• Manage filing and archiving of safety documents, in compliance with effective internal procedures and good documentation practices
• Research best practices in the industry involving drug safety and evaluate and oversee their implementation in the organization
• Other duties may be assigned

Necessary Skills and Abilities

• Good writing, organizational and communication skills
• Ability to lead teams with cross-functional representation is a key skill for this role
• Project management skillset a plus
• Must be capable of “managing from a distance” vendors responsible for delegated drug safety activities
• Ability to form collaborative relationships with business partners

Educational and Experience Requirements

• B.S. with training/advanced degree in a medical field (pharmacy/nursing, etc.)  
• 7-10 years of combined drug safety experience clinical research and medical/pharmacy experience. Experience may substitute for an advanced degree.
• Experience with safety operations and evaluation of safety data

Recruitment & Staffing Agencies

Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes.

Compensation & Benefits

Annualized base salary ranges from $130,000 to $200,000 plus target incentive; actual salaries will vary and may be above or below this range commensurate with several factors including experience, education, training, location, and merit.

Tonix provides a comprehensive compensation and benefits package which includes:

• 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
• 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

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.  In addition to federal law requirements, Tonix complies with applicable state and local laws governing nondiscrimination in employment.  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.  Tonix expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic, information, disability, veteran status, or any other characteristic protected by law. 

Salary : $130,000 - $200,000