AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson’s disease, and Pompe disease. AskBio’s gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing.

Our vision: Pioneering science to create transformative molecular medicines.

Our mission: Lead innovative science and drive clinical outcomes to transform people's lives.

Our principles:

• Advance innovative science by pushing boundaries. 

• Bring transformative therapeutics to patients in need.  

• Provide an environment for employees to reach their fullest potential.  

Our values:

• Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.

• Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.

• Embrace Responsibility. We are humbled by the enormity of our mission.  We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.

• Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.

• Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what’s right in every situation. Make clear commitments and follow through.

Position Summary

The Intern-Medical Safety & Pharmacovigilance will support the Pharmacovigilance team in data collection and analysis for the preparation of Development Safety Update Reports (DSURs). This role involves scheduling meetings with cross-functional stakeholders, medical writing and scientific analysis of literature, archiving of documentation in the MSPV record-keeping system, and ensuring timely regulatory submission. Additionally, the intern will work closely with the Safety Physicians and Pharmacovigilance Operations and Compliance to support them in assisting in the completion of day-to-day responsibilities.

This intern will report to the Director of Benefit/Risk Assessment, based in Research Triangle Park, NC.

Job Responsibilities

• Support the preparation of Annual Safety Reports  

• Learn pharmacovigilance processes, systems, and regulations

• Review the scientific literature

• Partner with cross-functional stakeholders to collect data

• Observe the clinical sub team meetings

• Participate in the planification of activities

• Assist the MSPV Operations and Compliance in the DSMB meetings preparation

Minimum Requirements

• Must be pursuing a Bachelor’s degree in the Life Sciences Field (Regulatory Affairs, Pharmacy, Biotechnology or related discipline)

• Must be at least a Senior in university at the time of your application

• Proficient with MS Office Suite and ability to learn new technologies quickly

• Excellent verbal and written communication skills

• Available to work full-time during the summer months (May-August)

• Proactive and solution-driven mindset

• Strong sense of accountability and ability to prioritize multiple tasks

• Excellent organizational skills and attention to detail

• Flexible and willing to support a variety of tasks for the Pharmacovigilance team

Preferred Education, Experience and Skills

• Students enrolled in a Master’s degree program in a related field encouraged to apply

• Prior internship, work, or volunteer/extracurricular experience

AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‐related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at (919) 561-6210 or sending us an email at [email protected].

Agencies:  Please do not contact any employee at AskBio about this requisition.  Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position.  All agencies must have a prior executed service agreement with AskBio prior to any search engagement.  If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency.