DSUR Writing - Pharmacovigilance @ Golden Opportunities

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DSUR Writing - Pharmacovigilance

Golden Opportunities
2 - 10 Years
Chennai
4 years ago
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Job Description

Job Role: DSUR Writer

Preferred Educational Qualification for the role:
Doctors (MBBS BAMS BHMS BDS MS/MD PhD) and/or graduate/postgraduate in life science pharmacy or nursing.
Preferred experience for the role:

More than 2 years of experience in medical writing and/or pharmacovigilance.
Responsibilities :

To perform safety periodic writing including assessment analysis and authoring of Development Safety Update Report (DSUR) assigned by the supervisor.
To effectively operate in an environment that requires negotiation persuasion collaboration and analytical judgment.
To have thorough knowledge to the tools and databases required during the process
To understand and interpret data/information and its practical application.
To perform all Pre-DLP activities and planning for all assigned reports as per the CLIENT training including conducting Kick off Meetings.
To draft and review SUSAR narratives.
To request and ensure the receipt of contribution from the various stake holders necessary for authoring of the assigned reports.
To ensure the completion of authoring QC review of the assigned reports within the specified timelines.
To perform peer review of the assigned DSUR and complete the corresponding QC checklists.
To provide daily progress update regarding the status of the assigned reports to the supervisors.
To track and ensure that the progress of reports is as per the client defined timelines.
To ensure the timely completion of all activities and trackers maintained for the project.
To ensure the completion of all assigned project related activities assigned by the supervisors.
To ensure compliance to SOPs and other process related documentation.
To impart trainings mentor and groom the new associates.
To provide innovative suggestions and ideas for process optimization.
To ensure that all DSUR related trainings are completed within allotted time period.
To achieve the supporting documents in respective repositories for reference.

LOCATION : Bangalore/ Mumbai/ Pune

Employement Category:

Employement Type: Full time
Industry: Bio Technology & Life Sciences
Functional Area: Pharmaceutical
Role Category: Documentation
Role/Responsibilies: DSUR Writing - Pharmacovigilance

Contact Details:

Company: Golden Opportunities
Location(s): Chennai

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Expected Salary (*)

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Functional area / Department (*):

Enter Skills (key skills, subjects, technologies & roles to use in search)

Write briefly about yourself, your experience and education (*)

Attach ResumeMax 2.38 MB (RTF, PDF, DOC, DOCX formats only parsed)

Please, check the file size and type.

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DSUR Writing - Pharmacovigilance @ Golden Opportunities

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