Clario Hiring for Sr. Drug Safety Associate Job at Mysore Full Time

• Function as primary point of contact for each group of therapeutic areas.
• Lead/Co Lead cross functional teams contributing to periodic safety reports in accordance with Global Pharmacovigilance and Risk Management (GPRM) business rules, standard operating procedures (SOPs), and global regulatory requirements.
• Support roles involved in creation of Aggregate Safety Reports (ASRs) (i.e. PSURs, PADER, DSURs, PBRER’s, Addendum to Clinical Overview’s, Addendum to PSUR’s, Summary Bridging Report’s and RMP Updates).
• Review aggregate safety data from the database and generate line listings (LL) and summary tabulations (ST) and include the LL & ST in the appropriate template.
• Compile the safety data into the relevant sections of periodic reports such as PBRER, PSUR, AdCO, PADER, and DSUR according to the client.
• Reviews and identify the literature that is selected for inclusion in the regulatory document that may lead to the signal detection.
• Ensure that narrative writing/safety report drafting, follow-up activities and all documentation are conducted per client approved project SOP, WI, convention and workflow in collaboration with quality assurance.
• Plan, organize, and manage daily work to meet service level timelines and deliverables.
• Work with the Aggregate Reporting lead to escalate issues or tasks outside the normal scope of work.
• Provide word and PDF versions of the final signed documents to the client.
• Participate in internal and external audits and inspections by clients and health authorities.
• Ensure adequate and appropriate training and training documentation.
• Cross check RMPs as required to draft aggregate reports
• Ensure appropriate and adequate resource allocation and back-up roles for project continuity and timely delivery.
• Quality delivery through a rigorous metrics-based approach.
• Ensure timeline are being met.
• Perform any other drug safety related activities as assigned

• Quality review of the Regulatory documents before they are sent to the client for review
• Perform data quality check on full draft safety reports and narrative batches
• Ensure all steps for aggregate report process is appropriately documented.
• Document all QC findings from the draft report review and notify, in writing, to medical writer/Medical reviewer
• Cross check RMPs as required to draft aggregate reports
• Notify QC identified issues that impact report to the PM
• Document and track all the QC review and findings and ensure resolution by PM
• Document and track resolution to QC review and findings
• Ensure all the steps of aggregate report process is appropriately documented

• Reading, understanding, and adhering to organizational standard operating procedures (SOPs)

• Assisting in establishing and enforcing departmental standards

• Working with internal staff to resolve issues
• Exploring new opportunities to add value to organization and departmental processes
• Helping others to achieve results
• Performing other duties as assigned

• Basic competence with medical and therapeutic terminology.
• Ability to work independently but guided by documented procedures, with appropriate support.
• Able to work effectively as part of a team.
• Understanding of patient safety regulatory obligations.
• Should be familiar with regulatory &pharmacovigilance guidelines.
• Should be familiar with pharmacovigilance terminology.
• Excellent attention to detail.
• Ability to deliver within established timelines.
• Fluency in English and excellent comprehension.
• Computer literate.
• Relevant product and industry knowledge.
• Experience with relevant software applications.

• Requires a proactive approach and excellent written/oral communication and interpersonal skills.
• Strong interpersonal skills required to interact with clients, management, and peers effectively.
• Effective cross‑department communication.
• Ability to document and communicate problem/resolution and information/action plans.

• Person should be familiar with MS Office Tools.
• Safety database knowledge.

Collaboration, Continuous Learning, Critical Thinking, Organizational Awareness, Results Orientation, Service Orientation