Drug Safety Associate
Proclinical is currently recruiting for a Drug Safety Associate with a pharmaceutical company located in Durham, NC.
- Responsible for ensuring local regulatory obligations for clinical safety reports are met to the local health authority, including expedited submission of IND Safety Reports as well as oversight of periodic aggregate report submissions for products to FDA.
- US Periodic Reports: Support safety management of reports. Support to include governance QC of reports; documentation of submission in Safety Database; documentation of compliance; assist and collaborate with vendor parties responsible for compiling reports, creation and maintenance of US Periodic report schedule.
- US IND Safety Reports (INDSRs): Support safety governance management of reports. Support to include monitoring for new INDs; confirming INDs configured on Safety Database; maintaining IND tip sheets; compiling INDSRs; making INDSRs available to regulatory submissions for reporting to FDA; making INDSR available for reporting to investigators.
- US Safety Governance email and US Safety Related Postal Mail: Triage mailbox/postal mail based on triage details
- Dear Health Care Provider Letters (DHCPL): Support compliance documentation of the dissemination of DHCPLs
- Archive and Document Management: Support in archiving information to relevant storage areas and managing file and storage solutions (e.g. share area and team sites)
- Perform other duties as assigned
Skills and Requirements:
- 1-2 years clinical safety or related experience
- Knowledge of GCP, clinical safety documentation and reporting of adverse events
- Understanding of medical and drug terminology
- Working knowledge of principles of data collection, manipulation and retrieval
- Basic safety database search skills
- Computer literacy
- Excellent skills in rapid and accurate data entry
- Good understanding of medical and drug terminology
- Knowledge of GCP, clinical safety documentation and reporting of adverse events, local regulatory requirements and pharmacovigilance methodology
- Working knowledge of local regulations, SOPs, and guidance documents
- Strong oral and written communication skills
- Sound organization skills
- Demonstrates planning and organizational skills
- Attention to detail but demonstrates pragmatism where appropriate
- Proven ability to handle high volumes of work accurately and rapidly
- Identifies issues/concerns in a timely and appropriate manner
- Self-motivated and capable of working independently
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Sarah Beshara at 2 67-477-3355 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.