Safety Scientist

Company Description

Mindlance is a national recruiting company which partners with many of the leading employers across the country. Feel free to check us out at http://www.mindlance.com

Job Description

Work from Home answer:

There is no routine work from home, but we do allow contractors on an
occasional basis at the discretion of the manager and dependent on
things such as work volume, employee being in good standing, etc.
Requests to work from home must be made in advance, and may be denied at
the discretion of the manager.
In instances of inclement weather, we would allow our contractor and
permanent employees to work (safely) at home

Contract duration 6 months with option to extend.


Assist with the preparation of adverse event reporting plans (AERPs)
and other plans as required
Maintain a listing of all administrative changes and updates
Ensure all processes as described are operational
Alert Project Management when activities fall outside SOW
Process and evaluate AE reports according to the customer's standard
operating procedures (SOPs): write the narrative, perform seriousness
rating and causality and expectedness assessment
Ensure the quality and accuracy of data used to support any regulatory
document, including but not limited to: ICSRs, aggregate data, requested
line listings
Assist in the reconciliation of clinical and safety databases
Contribute to the preparation and quality control of safety aggregate
reports, responses to authorities, company core data sheets, signal
detection and assessment reports
Perform literature review for identification of case reports and other
relevant safety information
Liaise with both internal and external vendors (clients, patients and
HCPs)
Review/Quality check (QC) of source documents, coding, data entry,
report generation and distribution
Monitor compliance metrics and ensure appropriate documentation when
deficient
Assist in evaluation and validation of systems to support safety
Other duties as assigned by management

Qualifications

Registered Nurse, Pharmacist, or other degree in a science or
health-related field
Good knowledge of global and local PV regulations and legislation, both
pre-and post-marketing required.
Minimum of 1 year of experience in a pharmaceutical company or a
service provider (e.g., CRO) with case processing responsibilities
Pharmacovigilance (PV) reporting experience should include drugs and
biologics. Experience with safety surveillance of vaccines and medical
devices a plus but not required
Proficient with case processing including use of coding dictionaries,
case narratives preferably within ARISg and/or Argus.
Proficient with computer programs (MS Word, PowerPoint, Excel)
Good communication, interpersonal interaction, and organizational
skills are essential
Ability to manage multiple client projects simultaneously with good
time management skills.
Fluent in English, additional language fluency a plus, but not required

Additional Information

Thanks & Regards,

Mahesh Kumar | Team Recruitment | Mindlance, Inc. | W: 732-479-4523

maheshk(at)mindlance(dot)com