Intern-Medical Safety & Pharmacovigilance

Ask Bio 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.

Ask Bio's gene therapy platform includes Pro
10, 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 Medical Safety and Pharmacovigilance (MSPV) team in data collection for safety governance meetings, file the outcome of the safety governance meetings in SharePoint, and document the results in the MSPV record-keeping system. This intern will also support DSMB members' documentation and record-keeping for onboarding, and coordinate schedules as needed for ad hoc or planned DSMB meetings.

The successful candidate will work closely with the Safety Physicians, Aggregate Report Lead, and Pharmacovigilance Operations and Compliance to support them in completing day-to-day responsibilities.

This internship is office-based in Research Triangle Park, NC and reports to the Senior Director of Safety Operations and Compliance.

Job Responsibilities

* Support collection of safety data for governance meetings

* Learn pharmacovigilance processes, systems, and regulations

* Observe Safety Review Committee meetings

* Participate in pharmacovigilance compliance activities

* Assist with documentation for DSMB members

* Maintain SharePoint sites for safety governance operational, Compliance, and DSMB meetings

* Collect and file meeting minutes and related documents

Minimum Requirements

* Must be pursuing at least a Bachelor's degree in the Life Sciences Field (Regulatory Affairs, Pharmacy, Biotechnology)

* Must be at least a Senior in a Bachelor's program at 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

* 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

* Available to work full-time during the summer months (May-August) at an Ask Bio office

Preferred Education, Experience and Skills

* Master's students are encouraged to apply

* Prior internship, work, or volunteer/extracurricular…