Senior Specialist, Drug Safety Submissions

Role Summary

The Senior Specialist Drug Safety Submission, also known as Pharmacovigilance (PV) Submission Specialist, will focus on ensuring the timely and accurate submission of global safety reports to regulatory authorities and investigators, ensuring drug safety and compliance. This role will also support the PV safety systems programming and maintenance and provide review and expertise for global Safety management plans and other PV study documents to ensure regulatory reporting accuracy.

Responsibilities

• Prepare and submit safety reports (e.g., Individual Case Safety Reports, Periodic Safety Update Reports and Development Safety Update Reports) to Global regulatory agencies.
• Ensure that all submissions adhere to relevant global regulations and guidelines.
• Contribute to the development and improvement of global safety reporting processes.
• Support the department with EudraVigilance registration issues and maintenance of EudraVigilance accounts.
• Manage and maintain safety data, ensuring accuracy and completeness.
• Collaborate with cross-functional teams to gather and share safety information.
• Participate in audits and inspections related to safety reporting.
• Support programming efforts in relation to PV safety systems for regulatory reporting.
• Assist with clinical study project set-up/close-out regarding regulatory reporting.
• Represent PVG in ImmunityBio internal and external team meetings.
• Resolve complex problems through in-depth evaluation of various factors and collaboration with stakeholders.
• Maintain up-to-date knowledge of required therapeutic areas and regulatory requirements for SAE processing.
• Assist in the generation and writing of DSURs and other periodic reporting.
• Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates.
• Perform ad-hoc and cross-functional projects assigned to support business needs and provide developmental opportunities.

Qualifications

• RN, pharmacist, or Bachelor‚Äôs degree in Health Sciences or health science field, with 5+ years of drug safety surveillance and/or pharmacovigilance or comparable relevant experience and training is required OR;
• Associate‚Äôs degree with 7+ years of drug safety surveillance and/or pharmacovigilance experience or comparable relevant experience and training is required.
• Experience in drug safety, pharmacovigilance and global regulatory reporting is required.
• Experience in using safety databases and reporting systems is required.
• Experience with safety database programming is required. (with ARISg a plus)
• Medical writing experience with PSURs, DSURs, SDEAs is preferred.
• Oncology experience is preferred.

Knowledge, Skills, & Abilities

• Strong understanding of pharmacovigilance principles, global regulatory requirements and safety reporting guidelines.
• Expert global knowledge of GCPs and regulatory requirements.
• Ability to coordinate complex global and domestic studies.
• Knowledge of international safety reporting processing.
• Effective problem-solving ability and project management skills.
• Effective mentoring skills and ability to train and lead others.
• Knowledge of Broad-based therapeutics
• Excellent oral, written communication skills and attention to detail.
• Ability to work within a team and independently as needed
• Excellent analytical and technical skills, including the ability to comprehend and integrate scientific data from a variety of sources.
• Proficiency with medical terminology.

Education

• RN, pharmacist, or Bachelor‚Äôs degree in Health Sciences or health science field, with 5+ years of drug safety surveillance and/or pharmacovigilance or comparable relevant experience and training is required OR;
• Associate‚Äôs degree with 7+ years of drug safety surveillance and/or pharmacovigilance experience or comparable relevant experience and training is required.

Additional Requirements

• This position works onsite or remote based on the candidate‚Äôs geographic location.
• Lift and carry materials weighing up to 20 pounds.