Dear *Professional*,
Hope you are doing great today...
This is *BABU, BDM FROM PANTAR SOLUTIONS INC*, we are an Information
Technology and Business Consulting firm specializing in Project-based
Solutions and Professional Staffing Services. Please have a look at below
position which is with our Client and let me know your interest ASAP. I
would really appreciate if you could send me your *MOST RECENT UPDATED
RESUME*:
*Pharmacovigilance Operations Consultant with Clinical Pharmacy
Exp.Marlborough, MA*
*3+ months*
*Consultant's LinkedIn profile must have been created before 2018*
*Need 9-10+ yrs of IT Exp. Profiles || Need Passport number, I94, Travel
History documents during submission for GC *
*Description:*
Reason: Peak Workflow Period
Department: Pharmacovigilance&RiskManagement
Job Category: Clinical
Job Title: Pharmacovigilance (PV) Operations Consultant
Duties: Duties
The PV Operations Consultant is responsible for the management of the
Pharmacovigilance (PVRM) and non-PVRM vendor(s) (e.g. Commercial) and will
be responsible for adverse event handling and reporting and for general
PVRM operations, including support of the global PV system. This role is
responsible for training management, including development and maintenance
of PV staff learning plans, assisting with compliance activities, quality
monitoring, management of the CTSA mailbox, and is the PVRM Team Room
administrator, including file management, archiving activities, and
document retention initiatives. Additionally, this position contributes to
audit and inspection preparedness, and is a member of a cross-functional
working team supporting PVRM audits and inspections. This position works
closely with the Information Management (IM) and Safety Science groups as
part of a matrix team to support PV activities.
*Essential Functions Required for Job:*
Work within the global PV system to ensure alignment in process / procedure
with regards to case processing operations. Works closely with the CTSA
team member responsible for PVRM and non-PVRM vendor compliance management
to address compliance issues originating with the vendor. Conducts routine
AE case quality checks and supports the IM team with ad-hoc projects such
as QC of test cases for special projects or during database upgrades or
migration. Supports PVRM vendors to the responsibilities outlined in the
contract and statement of work. Supports the development of a strategic
relationship with the vendor and understands the vendor's business to
ensure consistent and quality vendor performance. This also includes
liaising with other SMPA departments to ensure non-PVRM vendors are meeting
their AE training and reporting requirements. Manages a subset of scope of
the vendor responsible for rest of world reporting to investigational
licenses. Liaises with non PVRM groups responsible for organized data
collection schemes to ensure the collection and reconciliation of safety
information generated from these activities. Manages PVRM reconciliation
with internal and external stakeholders. Works closely with PVRM colleagues
/ functions in business-as-usual operations to ensure consistent and
efficient procedures and process in accordance with regulations and best
practices. Manages the annual review and release of companywide Adverse
Event (AE) policy training, ensuring that all training materials are
compliant with corporate policies, SOPs, and local/global regulations.
Manages PVRM document storage ensuring all pertinent documents are
processed and filed in accordance with SOPs. Manages archiving activities,
including interactions with archiving vendors as applicable. Serves as
records Information Management coordinator. Participates in audit and
inspection preparation as part of a cross-functional working team
supporting regulatory inspections and internal audits. Manages other PVRM
or cross-functional ad-hoc projects or assignments that require compliance,
training & strategic alliance input, supporting desired high-performance
"Safety First" culture in line with SMPA's values and reinforcing related
behaviors.
*Skills: SkillsKnowledge and skills (general and technical):*
Experience in case processing group or CRO preferred but not mandatory.
Understanding of U.S. regulations and a fundamental working knowledge of
global regulations and guidelines, e.g., US, EEA, UK, and Canadian
regulations and European & Canadian and ICH guidelines, GVP, and other
applicable guidance is preferred. Highly self-motivated and able to work
effectively with moderate supervision. Excellent time management and
organizational skills, the ability to manage multiple competing priorities,
and able to work effectively in multi-functional teams. Skilled in project
management. Excellent communication skills. Proficient in MS Office
applications, especially Word, Excel and PowerPoint.
*Other requirements (licenses, certifications, specialized training, and
physical or mental abilities required): Confidential Data:*
All information (written, verbal, electronic, etc.) that an employee
encounters while working at SMPA is considered confidential.
*Compliance:*
Achieve and maintain compliance with all applicable regulatory, legal and
operational rules and procedures by ensuring that all plans and activities
for and on behalf of SMPA are carried out with the best industry practices
and the highest ethical standards.
*Mental/Physical Requirements:*
Fast-paced environment requires handling multiple demands. Must be able to
exercise appropriate judgment, as necessary. Requires a high level of
initiative and independence. Excellent written and oral communication
skills required. Requires ability to use a personal computer for extended
periods of time.
*Education level and/or relevant experience(s):*
Bachelor's degree in a scientific or health-related field preferred. In the
absence of a bachelor's degree, at least six (6) years of relevant
experience in a clinical setting/pharmaceutical company. At least four (4)
years of experience in Pharmacovigilance.
Skills and Experience:
*Required Skills: *
CLINICAL PHARMACY
*Languages:*
English
Read
Write
Speak
*Minimum Degree Required: *Bachelor's Degree
*PLEASE NOTE:*
If for any reason this does not interest you or you felt uncomfortable by
any part of this email, I sincerely apologize. Please consider this E-mail
as a request for referrals and feel free in forward this email to anyone
whom you might find a fit.
*Thanks & Regards,*
Babu
Pantar Solutions Inc
1908 Cox Rd, Weddington, NC 28104
Email: babu (dot) s (at) pantarsolutions (dot) com
<http://pantarsolutions.com>
--
You received this message because you are subscribed to the Google Groups
"project managment" group.
To unsubscribe from this group and stop receiving emails from it, send an email
to [email protected].
To view this discussion on the web visit
https://groups.google.com/d/msgid/project-managment/CAHynwgqL_7vLZqcz5cqidJOeOH%2BFWKuN7f%2BbDzoQQTJZfMoJxw%40mail.gmail.com.
