Job ID: 2017-14725
Job Category: Clinical operations
Position type: Full time
Job Overview
ü Manage the
receipt and processing of all adverse event reports reported either
spontaneously from any source or from a clinical trial. This includes, but is
not limited to:
ü Entry of
safety data onto adverse event database(s) and tracking systems
ü Review of
adverse events for completeness, accuracy and appropriateness for expedited
reporting
ü Write patient
narratives
ü Code adverse
events accurately using MedDRA
ü Determine expectedness/listedness
against appropriate label
ü Identifies clinically
significant information missing from initial reports and ensures its collection
ü Ensure case
receives appropriate medical review
ü Prepare follow-up
correspondence consulting the medical staff accordingly.
ü Ensure all
cases that require expediting reporting to worldwide regulatory agencies are
processed swiftly and appropriately within required timelines
ü Reporting of
endpoints to clients, regulatory authorities, ethics committees, investigators
and Covance project personnel, if required, within study specified timelines
ü Provide independent
QC of AE reports for other members of the group
ü May execute
routine quality review of AE reports and aggregate reports for other members of
the group ensuring that case processing and data quality meet global regulatory
compliance needs including audit support.
ü Maintain a
strong understanding of Covance’s safety database conventions or
client-specific database conventions, as appropriate.
ü Participate
in signal detection, trend and pattern recognition activities, as appropriate.
ü Prepares
timely pharmacovigilance reports for products and safety issues, including
Individual Case Summary Reports (ICSRs) of Serious Adverse Events (SAEs),
Annual IND reports, European Annual Safety Reports (ASRs), Development Safety
Update Report (DSUR) Periodic Reports (PRs) line listings, and aggregate
reports.
ü Begin to
participate and demonstrate leadership on projects which enhance team and/or
division performance. This includes acting as a lead contact for projects
including global projects ensuring communication and process harmonization.
ü Work with
Data Management or client on reconciliation of safety databases, if
appropriate.
ü Monitor
workflow for assigned studies/programs to ensure all deadlines are met.
ü Draft/modify
and deliver safety presentations
o
Serious Adverse Event reporting at Investigator meetings
o
Client capabilities meetings, as appropriate
o
“Department Overview” to internal clients
ü Maintains a
comprehensive understanding of Covance PV&DSS’ Standard Operating
Procedures (SOPs), Work Instructions (WI), guidance documents and directives
associated with safety management, reporting and pharmacovigilance.
ü Possess
knowledge of other procedural documents, e.g. SOPs, etc. that impact
PV&DSS.
ü Assist in
the development of departmental Work Instructions (WI) and Standard Operating
Procedures (SOPs), as appropriate.
ü Ensure
compliant safety reporting in accordance with US and international reporting
regulations, SOPs and safety processing guidelines set forth by departmental
management team and the client.
ü Participate
in the generation of monthly status and other project-specific reports ensuring
the quality and accuracy of metrics/data are provided.
ü Support/train
less experienced safety staff in all aspects of case-handling, adverse event
reporting and other work, as needed.
ü Build and
maintain good PV&DSS relationships across functional units.
ü Demonstrate
role-specific Competencies on a consistent basis.
ü Demonstrate
company Values on a consistent basis.
ü Begin to
prepare Safety Management Plans (SMPs), Reconciliation Plans and other
safety-specific plans under supervision.
ü Responsible
for making decisions regarding adverse event reporting within the guidelines of
each specific project.
ü Assist
PV&DSS management to identify out of scope work.
ü Actively
participates in project team and client meetings and liaise with clients, where
appropriate.
ü Prepare
and/or participate in client or regulatory audits.
ü Assist in
the review of cumulative safety data for submission to Drug Safety Monitoring
Boards (DSMBs), regulatory authorities or clients.
ü Assist with
the set-up of, and the provision of data to Safety Committees/DSMBs.
ü Assist in
the co-ordination of endpoint committees, as required.
ü Any other
duties as assigned by management.
Education/Qualifications
ü Non-degree +
5-6 yrs safety experience*
ü Associate
degree + 4-5 yrs safety experience*
ü Associate
degree RN + 4-5 yrs safety experience*
ü BS/BA + 3-4
yrs safety experience*
ü MS/MA + 2-3
yrs relevant experience** (1-2 yrs safety experience)
ü Pharm D + 1-2 yrs relevant
experience** (1 yr safety experience)
For Pharm
D, a one year residency of fellowship can be considered relevant
experience.
Degree preferred to be in one or more of the following
disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and
Chemistry.
*Safety experience includes actual experience processing
AE/SAE reports, generating narratives, queries, working within safety
databases, and experience with regulatory submissions.
**Relevant experience includes experience in the
pharmaceutical, biotechnology, or CRO industry, partly in related areas such as
Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical
Data Monitor, Regulatory Affairs, or Quality Assurance.
Experience
o
Good verbal, written and presentation skills.
o
Good communication.
o Ability to interact and influence with line and middle
management, staff and external contacts on a functional and tactical level.
o
High degree of accuracy with attention to detail.
o
Functions as a team player.
o
Ability to present and share useful business information
across departments and functions.
o
Ability to anticipate and identify problems and take
appropriate action to correct.
o
Knowledge of medical and drug terminology
o
Knowledge of Good Clinical Practice (GCP) related to
clinical safety documentation
o
Knowledge of ICH Guidelines
o
Knowledge of Medical Device reporting desirable
o
Knowledge of worldwide regulatory requirements and
reporting of adverse event for both marketed and investigational products.
o Good knowledge and understanding of industry and R&D
processes and objectives.
o Ability to work independently with minimal supervision
o Good keyboard skills,
preferably with knowledge of MS office and Windows would be beneficial.
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