The posting
Job Overview:
- Responsible for the submission of Individual Case Safety Reports (ICSRs) following Sponsor standard operating procedures, internal business practices, and regulatory guidance documents, to ensure compliance with worldwide safety and Pharmacovigilance regulations.
Summary of Responsibilities:
- Responsible for reporting of ICSRs arising from post marketing and Interventional Clinical trial sources to Regulatory Authorities.
- Responsible for distributing ICSRs to Business Partners/License Partners per applicable Pharmacovigilance Agreements.
- Responsible for various formats of ICSR reporting that are submitted, such as xml, CIOMs, MedWatch format and E2B gateway reporting and transmission.
- Responsible for portal submissions, courier, and manual email submissions and attachments like CIOMS, MEDWATCH.
- Responsible for ICSR regulatory submissions for device reports and vaccines, as applicable.
- Responsible for monitoring submission workflows to ensure regulatory reporting within applicable due dates.
- Monitors and tracks E2b acknowledements.
- Responsible for supporting investigation into compliance investigations.
- Responsible for late case tracking and preparation of submission metrics.
- Performs the quality checks as applicable for “no submits” and cases submitted.
- Monitor and facilitate resolution for ICSR failed distributions and submissions.· Provides support for other activities such as daily report review, monitoring group mailbox, ad hoc data analyses.· Identifies and communicates concerns and issues which may require raising tickets with Support Desk.· May be requested to attend audits or inspections.
- Ability to work well with other colleagues and functions within the organization. Self-motivated and target oriented. Excellent written and verbal communication and interpersonal skills. Ability to produce quality materials within tight timeframes, willingness to work in a flexible schedule.
Qualifications (Minimum Required):
- Registered Nurse OR Health/Biomedical Degree (BS, PhD, or other related scientific degree/qualification) OR Licensed Practical Nurse without bachelor’s degree but with knowledge of Drug Safety usually exhibited by 2-3 years’ experience in pharmaceutical safety-related role.
- Pharmaceutical industry experience is preferred.
Required Skills/Abilities
- Intermediate Information Technology Skills Data entry experience desired Accountability for delivery of results Decision making skills. Problem solving skills. Proactive approach/uses own initiative. Manages own work, able to prioritize, plan and organize work assignments and work under strict timelines. Ability to follow guidelines, working practices etc. Experience of working with SOP/WI preferred Quality oriented, with attention to detail/accuracy Flexibility/Adaptability
- Positive attitude
Experience (Minimum Required):
- High degree of accuracy with attention to detail.
- Functions as a team player and offer peer support as needed.
- Good written and verbal communication skills.
- Ability to work independently with moderate supervision.
- Good keyboard skills with knowledge of MS Office and Windows application would be beneficial ¨ Mentoring skills preferred.
Preferred Qualifications Include:
- Office Environment or remote.
Learn more about our EEO & Accommodations request here.
