Drug Safety Associate

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


Pharmacovigilance and Safety

Full Time

11 Aug 2021