[New Job Opening] Drug Safety Associate job Vacancy in Bengaluru, Karnataka

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Job Details:
Position Name :
Drug Safety Associate
Location:
Bengaluru, Karnataka
Job ID :
0edd1da25784e90e
Description : Job Description
We are currently seeking a Drug Safety Associate, the role will include responsibility for:
Handling medical information calls/queries.
Developing all required documents for the Medical Call Center
Training associates for the Medical Call Centre and performing quality checks for live cases
Ensuring questions and concerns are processed and communicated with patients and referral sources both verbally and in writing in a timely manner
Adhering to and implementing all company policies and procedures, including but not limited to, clinical programs
Resolving customer questions or concerns
Maintaining and updating customer information as needed
Escalating calls or challenges to a supervisor when necessary and appropriate
Tracking call-related information for auditing and reporting purposes
Providing feedback reports on call issues related to downtime and/or training issues
Up-selling the services of the company/organization to customers as necessary
Exhibiting a detail-oriented etiquette and friendly attitude at all times when answering telephone calls
Case processing: completion of full case information on the database, including quality review to ensure accuracy and completeness
Triage of incoming cases to prioritize for daily workflow management
Completion of remaining case data entry (including narrative or auto-narrative), manual coding, label, and approval
Preparation of SUA summary: Analysis of Similar Events
Performing quality review of ICSR which includes review of source documents and ensuring that the case is accurate and that corrections to the case, if applicable, are incorporated.
Liaising with different functional teams/stakeholders as appropriate to clarify appropriate information required for case processing to address project related issues
Other activities relating to case processing as appropriate per case, including but not limited to: Single case unblinding, Serious Adverse Event (SAE) /Adverse Event (AE) reconciliation, deviation memo preparation, deletion/admin edit requests, review protocol update request forms for accuracy
Participating in designated activities to support revision/creation of case processing procedural documents
Reading and acknowledging all necessary internal and sponsor Standard Operating Procedures as required.
Participating in local or global project teams, including on-time delivery of assigned responsibilities
Overseeing, improving, and contributing to procedures and performance
Collaborating in the development, review, and initiation of SOPs
Interacting with staff in other functional areas within the company to ensure the highest level of client satisfaction through successful execution of projects
Identifying documents and appropriately resolving out-of-scope work as directed by senior management
Maintaining working knowledge of GCPs and regulatory requirements relating to clinical and PV teams to assure compliance with regulatory standards
Mentoring other staff as directed by Senior management and by consistently displaying exemplary work ethics, compassion and integrity, support Senior Management’s leadership of both the department and the company
Providing oversight of operational activities and sound understanding on project plans/documents
Participating in team meetings and providing regular feedback to the management on operational metrics and other challenges/issues
Executing administrative operational tasks as required
Performing other duties as assigned
Desirable Skills and Experience
MICC
Bangalore, India
Life Science Graduate
Associate
Pharmacovigilance and Safety
Full Time
11 Aug 2021
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