Intern-Medical Safety & Pharmacovigilance

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 Parkinsons disease and Pompe disease. AskBios 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 peoples 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 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 whats 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 Bachelors degree in the Life Sciences Field (Regulatory Affairs Pharmacy Biotechnology)

• Must be at least a Senior in a Bachelors 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 AskBio office

Preferred Education Experience and Skills

• Masters students are encouraged to apply

• Prior internship work or volunteer/extracurricular experience in the pharmaceutical or biotech industry

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 jobrelated 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 or sending us an email at .

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.