Senior Drug Safety Assistant
- Parexel
- 1 - 4 Years
- Mohali, Chandigarh
- 4 years ago
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Job Description
Administrative/Technical Assistance support for aggregate reporting activities including:
Running daily queries on the client database
Handling and reconciliation of generic client mailboxes (as applicable)
Retrieving Safety Surveillance Strategy Sheet (SSSS) from Client signal management tool and saving relevant documents of Signal Evaluation Reports (SERs) in the dedicated repository.
Maintenance of data on Key Performance Indicators (KPIs),
Safety database / tracking system and related administrative activities
Data configuration, generation and reconciliation for scheduled and unscheduled aggregate safety reports (as applicable)
Maintaining aggregate reports calendar/contacts list
Generation, preparation, coordination, compilation, publishing and distribution of aggregate reports including not limited to PSRIs (Periodic Safety Report for Investigators), Interim line listings reports, PBRERs, PSURs, DSRs etc.
Preparing articles in eCTD format
Collaborate with aggregate team members to perform assigned tasks, and interact with other stakeholders on relevant deliverables but not limited to (e.g., PBRERs/PSURs, DSR, RMP, PADERs, Line Listings, Monthly Signal Report)
Initiate/conduct searches in internal and Client databases per requirements
Complete assigned tasks for other report deliverables (e.g., table set up, formatting, entering basic template information) under the direction of the report owner
Complete assigned tasks that support the department (e.g., document archival, maintenance and QC of the aggregate reports calendar, assist with project management for the aggregate group
Complete the quality review process for assigned deliverable (as applicable), responsible for identifying discrepancies if any, and determining the reasons for discrepancies
Checking and updating the Master Planning Table (MPT), where required
Providing submission-ready documents including but not limited to PSR Line Listings and literature for Risk Management Plans (RMPs), Addendum to Clinical Overviews (ACOs) and Clinical Overviews (COs)
Extracting and formatting the sales data from client database for inclusion in aggregate reports
Performing quality check of Line Listings, Submission Readiness, and sales data as per client requirements
Liaising and collaborating with the relevant function at the clients end to facilitate the delivery of high-quality work
Recognizing potential issues and interacting with internal or external contacts to resolve issues
High level of flexibility and ability to (re)prioritize work
Compiling of PSR report body and appendices for publishing
Generation and Publishing Periodic Safety Report for Investigators (PSRI), as applicable
Training
Provide assistance to Line Manager/ Project manager in managing training related activities
Managing user profiles in client learning management system
Management of relevant certifications to the users in client learning management system as per their job roles
Modification of learner profile attributes like manager name, department/organization, location etc., as required in client learning management system
Monitoring and providing interim compliance reports
Creation of Courses/Offerings in client learning management system
Publishing on-line training content (e-learning modules, quizzes, evaluations) on client learning management system
Training and Mentoring of Technical Associates for aggregate reports and ICSR activities (new starts), as required
General Administrative support including:
Assisting in audits, development of templates and guidelines
Arrange project related training and maintain project specific trainings overview and records, including study specific system training members
Training and Mentoring new team members, as required
Qualifications
Bachelors/Masters in computer applications
or Masters in Business Administration or IT and equivalent degree
>1 year of relevant experience
Employement Category:
Employement Type: Full timeIndustry: Full timeFunctional Area: PharmaceuticalRole Category: PharmaceuticalRole/Responsibilies: Senior Drug Safety AssistantContact Details:
Company: Parexel InternationalLocation(s): Mohali, Chandigarh+ View Contact
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Parexel
As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will...
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