Medical
Sciences Opportunities at Parexel
M.Pharm/BDS
Basic
Function:
Preparation
of aggregate reports and update/preparation of RMPs in accordance with client
procedures and regulatory requirements
Principal
Functional Responsibilities:
•
Preparation of and/or assistance in the preparation of Aggregate Reports
including, but not limited to, Periodic Benefit-Risk Evaluation Reports
(PBRERs), addendum to Clinical Overviews (ACOs), Periodic Safety Update Reports
(PSURs), Signal Evaluation Reports (SERs) and US Periodic Adverse Drug
Experience Reports (PADERs) for pharmaceutical products, in accordance with
client SOPs and requirements/ conventions, as required
•
Preparation of and/or assistance in the preparation of other reports like Risk
Management Plans (RMPs)
•
Performing quality check of Aggregate reports/RMPs as per client requirements
•
Liaising and collaborating with the relevant function at the client’s end to
facilitate the delivery of high quality work
•
Interacting with internal or external contacts to resolve issues related to the
assigned work
•
Communicating/discussing issues related to the assigned work with the Document
Manager/Project Manager
•
Mentoring and training new team members on report writing, as required
•
Maintaining an awareness of the performance metrics measured by client (where
applicable) and striving to remain within established limits
•
Maintaining a good working knowledge of the safety profile of assigned drugs,
labeling documents, client's guidelines, procedures and SOPs, and international
drug safety regulations
•
Maintaining an awareness of global regulatory requirements and reporting
obligations and organizing workload to ensure compliance with internal and
regulatory timelines
Note:
The above statements describe the general nature and level of work being
performed, and are not an exhaustive list of all responsibilities required for
the position.
Qualifications
M.Pharm/BDS
Per
the requirement, candidate should have experience of 1-2 years of aggregate
report writing.
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