Description

Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines addressing unmet patient needs. We have more than 150 US and International patents (including applications) and have marketed several branded and generic products in the U.S., have licensed our products in the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.

Our science and technology make us unique, but our team members set us apart; they are the engine that fuels Tris' passion and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company's success. But of equal importance to each member of the team is how we interact with one another. We believe in each other and in respectful, open and honest communications to help support individual and team success.

We have an immediate opening in our Monmouth Junction, NJ facility for a Director, Drug Safety.

The Director, Drug Safety is responsible for planning, directing, coordinating and prioritizing activities of the product safety team and providing oversight of Pharmacovigilance (PV) vendors in all aspects of PV activities for products both marketed and in development. These activities/responsibilities include, but are not limited to: medical analysis and decision making for the development of ad hoc aggregate safety reports, periodic safety reports, signal detection activities and risk management planning.

The incumbent works cross-functionally with counterparts/teams in Clinical Development, Regulatory Affairs, Manufacturing, Quality, etc. to identify, evaluate and communicate safety observations.

The incumbent functions independently as a subject-matter expert (SME) while working collaboratively with key internal and external stakeholders to ensure high quality submissions are made to the Food and Drug Administration (FDA) to meet company goals.

ESSENTIAL FUNCTIONS

* Assists and supports the development, implementation and maintenance of a highly compliant, effective and ethical PV system

* Participates in drafting and implementation of PV contracts, agreements and budgets, and oversees day to day, operational performance of safety vendors

* Oversees adverse events handling, including individual case reviews, assessment of expectedness and relatedness; Collaborates closely with Regulatory Affairs or appropriate vendors on expedited reports, as appropriate

* Participates in, and/or leads, key Drug Safety activities including, but not limited to: safety data review, signal detection, risk communication including safety information updates, potential risks mitigation, etc.

* Collaborates with appropriate clinical, medical, quality and regulatory counterparts and others across business to provide input and oversight for all safety and PV issues

* Provides input and expertise to aggregate safety reports (i.e., development safety update reports, periodic benefit risk evaluation reports, etc.)

* Oversees reconciliation of safety data in pharmacovigilance and clinical trial databases

* Ensures audit and inspection readiness of Drug Safety team at all times; Ensures internal regulatory/PV processes and procedures

are well documented and support compliant regulatory/PV activities

* Reviews safety data exchange and/or PV agreements with appropriate business partners and assumes accountability in ensuring compliance with safety data exchange activities

* Reviews and/or contributes to safety sections of key study documents such as (i.e., Investigator Brochures, protocols, statistical analysis plans, informed consent forms, Clinical Study Reports (CSRs), etc.); Provides expert safety guidance to clinical trial project teams and/or external partners to develop procedures and logistics for clinical trials

* Assists in preparation of response to regulatory inquiries related to safety; Prepares training materials for internal and external safety presentations, as applicable

* Actively participates in meetings with FDA and other Health Authorities, as required; Represents Drug Safety, establishes and manages good working relationships and provides drug safety advice to internal and external teams

* Manages, coaches and mentors a small team of direct reports

Requirements

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

* Healthcare professional or related degree (MD, RN, BSN, PA, NP, PharmD, etc.) and minimum 7 years global Drug Safety/Pharmacovigilance clinical trial and post marketing experience in a pharmaceutical or biotechnology industry in positions of increasing technical and leadership responsibility

* Current leadership and oversight experience for global safety activities, operations and risk management strategies in pre and post marketing environments

* Expert knowledge on Food and Drug Administration (FDA) safety regulations, International Conference on Harmonisation (ICH) Guidelines, Good Pharmacovigilance Practices (GVPs) and other applicable safety and regulatory guidance documents

* Proficiency with drug safety databases (i.e., Argus), electronic data capture (EDC) systems, Medical Dictionary for Regulatory Activities (MedDRA) and World Health Organization (WHO) Drug dictionary coding

* Experience supervising or overseeing outsourced vendor activities in compliance/regulated pharmaceutical activities

* People management experience

* Ability to influence without direct authority

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-hybrid