Drug Safety Associate job in Durham, USA

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

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Phone Number*

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Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Pharmacovigilance, PV Officer/Associate, Good Pharmacovigilance Practice (GVP)

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for a Drug Safety Associate with a pharmaceutical company located in Durham, NC.

Job Responsibilities:

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

To Apply:

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.

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