Associate Clinical Safety Surveillance Director

United Therapeutics•Rtp, NC

1d•Hybrid

About The Position

The Associate Clinical Safety Surveillance Director plays a key role in management and oversight of SAEs and events of special interest across our UT sponsored clinical trials. This position provides strategic direction to the team and vendors with respect to changes in business practices for efficiency, quality, and compliance impacts. Overall, this role is critical in ensuring that operational aspects of SAE/AESI collection, query management, etc. are managed with rigorous global standards in proper documentation, evaluation processes, and decisions to support the overall global safety surveillance program and proper management of benefit/risk of UTC developmental products. Function as a horizontal enterprise leader supporting safety governance architecture, inspection readiness posture, and sustained regulatory compliance across the UT Sponsored Clinical Trial portfolio by influencing strategy to address internal and external business and regulatory issues; serving and being recognized as an expert within organization, both inside and outside UT GPS; anticipating potential internal and/or external business challenges or regulatory issues and recommend solutions; developing the tools and knowledge requirements necessary for the developmental programs we support as it relates to pharmacovigilance.

Requirements

Bachelor’s Degree in a related field (chemistry or biology), or BSN, and 12+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs (clinical trial cases), or Master’s Degree in a related field (chemistry or biology), and 10+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs (clinical trial cases), or Doctor of Pharmacy (PharmD) PhD, MD/DO or international equivalent, and 7+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs (clinical trial cases)
5+ years of experience in vendor management and/or CT oversight
5+ years of clinical trial or product development experience
3+ years of previous functional lead/people management experience
Previous experience using Argus (preferred) or other safety databases
End-to-end case processing (including data entry, QC, medical review, regulatory submissions)
Project management skills and ability to organize and deliver large, complex projects independently
Working knowledge of drug development processes and activities, including but not limited to having the ability to explain the legislative framework supporting all aspects of drug development & registration of medicines, ensuring their safety
Working knowledge of global regulations, guidelines and industry best practices for end-to-end case management for devices, biologics, and drug products (in development)
Working knowledge of MedDRA coding
Strong written and verbal communication skills, including but not limited to the ability to communicate safety issues in a variety of formats required to meet the needs of the intended audience and contributors
Strong analytical thinking to diagnose common situations, gather and review relevant information, and recommend solutions
Ability to work effectively across functions; understands objectives, activities, and required contributions of internal partner functions
Willing and able to challenge current state, suggest alternative approaches to improve work practices, and commit to defined changes
Adaptable and can work effectively in ambiguous situations
Prior clinical PV management experience

Nice To Haves

Previous experience using Argus

Responsibilities

Evaluate, strategize, and execute process changes in response to regulatory updates, ensuring the effectiveness and efficiency of end-to-end clinical trial SAE and AESI handling for developmental pulmonary product(s).
Initiate, plan, coordinate, and implement project plans to enhance process efficiencies and support business goals and objectives.
Strategize and implement functional and department goals for the GPS Clinical Trial Oversight team.
Maintain unified SAE and AESI handling operating procedures (i.e. Safety Management Plan) and monitor systems to ensure all SAE and AESIs are processed and submitted per UT SOPs and industry standards.
Evaluate and sign off on all SOPs related to SAE and AESI handling for developmental product(s).
Ensure adherence to global safety regulations and guidelines by overseeing the collection, management, and reporting of safety data for UTC’s developmental programs, identifying risks and implementing corrective actions as needed.
Provide strategic guidance to ensure compliance with global regulations and guidelines for developmental PV case management, and reporting of ICSRs.
Remain current on global regulations, guidelines and industry best practices for end-to-end developmental case management, ensuring compliance with global regulations and guidelines.
Act as the main point of contact and functional manager for day-to-day questions or issue escalation regarding SAE and AESI handling processes.
Participate in strategic discussions with other team members of GPS to ensure process compliance and operational input.
Strategic oversight and management of GPS clinical trial oversight team metrics.
Develop, facilitate, and provide training and training materials for SAE and AESI handling for developmental product(s) in accordance with SOPs, global regulations, guidelines, SMPs, and conventions for investigator sites, investigators and others.
Direct and manage direct reports to include responsibilities for training, goal setting & achievement, performance evaluations/management, coaching, mentoring, career development and provide support for recruitment process (as needed).
Act as the point of contact for inspections and audits related to UT GCP safety operations handling activities.
Conduct root cause analysis of inspection or audit findings and ensure appropriate CAPA is in place to address the findings.
Review and approve deviations/CAPAs for any related activity as necessary.
Initiate and lead the development and implementation of new or revised SOPs.
Update and maintain procedural documents to reflect current practice related to GPS SAE and AESI case handling/operational handling.
Remain current on all global and local GCP and GVP regulations supporting Clinical Trials in the PV setting.
Perform additional responsibilities as required, ensuring alignment with corporate strategy and evolving business needs.