Senior Pharmacovigilance Associate

Theradex Oncology•Princeton, NJ

19h•$80,000 - $115,000•Remote

About The Position

We are seeking a Senior Pharmacovigilance (Drug Safety) Professional. In this role, you will champion cross-functional collaboration with internal medical, data, and regulatory teams, as well as external vendors and auditors, to manage serious adverse events and guarantee regulatory compliance.

Requirements

Bachelor’s degree in a life sciences field or equivalent (e.g., Biological Sciences, Pharmacy, Nursing) or relevant professional training and certification within the pharmacovigilance function
3-4 years Drug Safety experience or related
Case processing experience
SAE and SUSAR experience
Prior experience with ARGUS safety database, including technical proficiency in XML generation, electronic gateway submission, and study/console configuration
Willingness to be on call for after hours and weekend safety desk coverage
Maintaining strong operational mastery
Working knowledge of current EU and UK pharmacovigilance legislation, guidelines, and EudraVigilance systems
Thorough knowledge and application of requirements, including clinical safety documentation
Proficiency in MedDRA and WHO-DD coding dictionaries
Deep understanding of specific sponsor and client internal Standard Operating Procedures
Strong analytical and technical skills to anticipate project roadblocks and implement proactive solutions
Ability to set, track, and achieve short- and long-term project goals
Excellent written, oral, and interpersonal communication skills
English fluency: Full professional proficiency in written and verbal English
Superior accuracy with strict attention to detail
Proven ability to work productively both independently and within team environments
Strong organizational skills and time management
Advanced knowledge of Microsoft Word and Excel

Nice To Haves

EudraVigilance and/or XEVMPD user certification is a plus
Previous experience with randomized blinded studies and automation functionalities in ARGUS

Responsibilities

Prepare and implement study-specific Safety Management Plans (SMPs), Serious Adverse Event Report Forms (SAERFs), and completion manuals
Contribute to the development of safety-related clinical documents, including SOPs and trial protocols
Maintain up-to-date knowledge of the protocol and scope of work for all assigned projects
Manage the receipt, tracking, and processing of SAE reports and supporting documents according to the SMP (including after-hours monitoring if required by sponsors).
Review reports for accuracy, enter safety data into the Theradex safety database, write patient narratives, and code events accurately using MedDRA
Identify significant missing information, prepare follow-up correspondence, and ensure all cases receive appropriate medical review
Provide independent quality control (QC) of SAE reports processed by junior colleagues
Ensure cases requiring expedited reporting to regulatory agencies are processed within SMP timelines
Prepare safety reports for Sponsor approval, regulatory submission, and investigator notification
Submit safety reports to regulatory agencies, Central Ethics Committees (CECs), and investigators, as required
Notify the Sponsor and clinical team of SAEs according to project requirements
Reconcile the Theradex Safety and clinical databases, coordinating with data management and CRAs to resolve discrepancies
Coordinate the periodic review of safety data by Medical Monitors at pre-determined intervals
Participate in signal detection, trend analysis, and pattern recognition activities
Collaborate with the Global PV team to maintain the pharmacovigilance section of the Trial Master File
Maintain study-specific records for SAEs and safety reports
Ensure audit preparedness and provide direct support during regulatory inspections
Train and support junior colleagues, new staff, and general study team members on safety processes
Actively participate in Pharmacovigilance team meetings