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发帖数: 12 | 1 If you are interested, please send your resume with the targeted position to
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1. Data Entry Coordinator
Location:Berkeley Heights, NJ
Total hours: 528
• Conduct full data entry from source document as per the GDSRM
conventions -all cases globally including complex cases involving medical
records and literature cases
• Interpretation of medical source documents for data entry into
the safety database including extraction of appropriate laboratory data and
diagnostic testing
• Identify and confirm the appropriate timeline path for all cases
based on the serious criteria
• Ensure the adherence to internal and external timelines for case
processing to maintain regulatory reporting compliance
• Identify case sources as defined by GDSRM conventions
• Utilize clinical tracking databases to retrieve study information
for entry into the safety database
• Review and resolve ARISg validation errors
• Participate on project teams i.e. conventions manual, Six Sigma,
• QC of receipt data which includes receipt date, identification of
product quality complaints
• Execute predefined follow up measures and due diligence
• Liaise with the Workflow Manager to resolve processing and
workflow issues
2. Safety Specialist (AMER)
Location: Morrisville, NC
total hours: 8343
The Safety Specialist performs day-to-day adverse event reporting and
subsequent Pharmacovigilance (PVG) activities
performed within a highly regulated environment and driven by strict
timelines. Pharmacovigilance
activities include but are not limited to collection, monitoring, assessment
, evaluation, research and
tracking of safety information. Coordinates and performs adverse event data
entry, coding and
assessment of adverse events, case review, follow-up, tracking of reports,
and regulatory reporting
activities. Effectively collaborates with various parties such as: project
team members, client contacts,
investigators, and adverse event/ reporters, and third party vendors. May
assist in the preparation of
departmental and project-specific procedures and processes, prepare for and
attend audits, kick-off and
investigator meetings.
Job Scope:
Pharmacovigilance activities are a key performance measure for clients and
PPD. Associated with this
position, there is a high degree of liability. Errors made in
pharmacovigilance services could affect patient
safety, result in the loss of current and/or future contracts, as well as
incur regulatory/legal action.
Qualifications:
Minimum Required Education and Experience:
Bachelor’s degree in Nursing, Medical Technology or Pharmacy with
2+ years of clinical
experience
Or Life Science degree with 2+ years of clinical experience and 1
year of pharmacovigilance
experience
Or equivalent combination of education, training, and experience
that provides the individual
with the required knowledge, skills, and abilities to perform the job
Required Knowledge, Skills and Abilities:
General understanding of pathophysiology and the disease process
Detailed knowledge of relevant therapeutic areas as required for
processing AEs
Strong critical thinking and problem solving skills
Good oral and written communication skills including paraphrasing
skills
Good command of English and ability to translate information into
local language where
required
Computer literate with the ability to work within multiple
databases
Previous exposure to Microsoft Office packages (including Outlook,
Word, and Excel)
Understanding the importance of and compliance with procedural
documents and
regulations
Ability to manage and prioritize a variety of tasks and meet strict
deadlines with limited
supervision
Strong attention to detail
Ability to maintain a positive and professional demeanor in
challenging circumstances
Ability to work effectively within a team to attain a shared goal
3. Quality Systems Specialist
Location: Lexington, MA
Total hours: 1744
Provide support to the Operational Quality Systems Group to ensure the CAPA,
Change Control and Deviation processes deliver results efficiently and
effectively. Collaborate with the business process owners (BPOs) to assist
process users and customers with guidance on the processes and to ensure
successful execution of the processes through tracking, trending and general
oversight for compliance.
Responsibilities
Describe the essential daily job functions and include % of time spent on
each.
% of Time Job Function and Description
20% Maintain status reports for systems and drive compliance to agreed
upon dates
20% Support the BPOs in providing technical, procedural, and compliance
based guidance to system users as needed
20% Perform analysis and report on trend data. Report and escalate system
and process performance metrics to the Business Process Owners (BPOs).
15% Support training for Quality Systems processes as needed
15% Support the BPOs in follow-up with record owners and tracking and
trending of record status
10% Other duties as assigned by management
Education and Experience Requirements
Include educational requirements or equivalency, required years and type(s)
or experience, and
necessary licenses or certificates. Specify which are required and which are
preferred. For UK,
please do not use years of experience due to UK Legislation
• College degree preferred
• Experience with Quality Systems required
• Change Control, CAPA and Deviation experience related to GMP /
GDP / Medical Device preferred
• TrackWise experience a plus
Key Skills, Abilities, and Competencies
Describe critical skill and abilities needed to successfully perform the job
, which should be
representative of the knowledge, skills, and abilities required. Reasonable
accommodations may be
made to enable individuals with disabilities to perform the essential
functions.
• Ability to speak effectively and communicate directly with all
levels of personnel in a global environment
• Ability to write routine reports and correspondence for internal
and external customer communications
• Excellent attention to detail
• Strong organizational skills
• Computer literate—experience with Microsoft Office (specifically
Excel and PowerPoint) and TrackWise preferred
• Strong self-motivation and ability to work under limited
supervision
• Ability to work in, and be adaptable to, a diverse, dynamic, and
team-oriented environment
• Strong compliance mindset
• Ability to work independently
• Ability to solve problems and analyze data
• Contribute to a team-oriented environment
• Work under challenging deadlines and be accountable for
completing work within specified time periods
• Effectively communicate with all departments within Shire.
The person in this role will be instrumental in working with other members
of the Tech Ops and R&D organizations focused on the CAPA, Change Control
and Deviation processes to compliantly and efficiently achieve
organizational goals.
The person in this role must have the ability to analyze data, quantify
risks, and identify gaps independently.
Must have the ability to propose solutions to problems and escalate issues
with proposed solutions to management as necessary.
The person in this role must be able to make decisions on his/her own as it
pertains to individual projects, managing priorities, and timelines.
Consult with supervisor and other subject matter experts as appropriate. |
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