Layambhica Valavala

My responsibilities:

• 3 years of authoring and contributing to numerous aggregate safety reports including PADERs, and PSURs as well as a variety of clinical safety documents including safety management plans and safety date for clinical reports.
• Supervise workflow of staff in the pharmacovigilance department for both post-marketing and clinical studies.
• Client interaction including addressing client questions and client notifications.
• Schedule and conduct Pharmacovigilance training for call center, medical information and pharmacovigilance staff.
• Participate in development and continuous improvement of processes and workflow including SOPs, task descriptions, narrative templates, coding and assessment conventions and job descriptions.
• Created employee schedules to align coverage with forecasted demands.
• Developed loyal and highly satisfied customer base through proactive management of team customer service strategies.
• Mentored team members to enhance professional development and accountability in workplace.
• Defined clear targets and objectives and communicated to other team members.
• Evaluated employee performance and conveyed constructive feedback to improve skills.
• Streamlined and monitored quality programs to alleviate overdue compliance activities.
• Opened and closed location and monitored shift changes to uphold successful operations strategies and maximize business success.

My Responsibilities:

• Built strong relationships with customers through positive attitude and attentive response.
• Monitored time and attendance, enforcing compliance with company procedures relating to absenteeism.
• Monitored team performance and provided constructive feedback to increase productivity and maintain quality standards.
• Held weekly team meetings to inform team members on company news and updates.
• Supervised team members to confirm compliance with set procedures and quality requirements.
• Assisted in recruitment of new team members, hiring highest qualified to build team of top performers.
• Worked with team to identify areas of improvement and devised solutions based on findings.
• Managed leave requests and absences and arranged covers to facilitate smooth flow of operations.
• Communicated KPIs outlined in annual plan to inform employees of expectations and deliverables.
• Developed effective improvement plans in alignment with goals and specifications.

My Responsibilities:

• Managing the company’s safety database, including data entry, quality checks, and user access.
• Ensuring the timely and accurate reporting of adverse events to regulatory authorities and other stakeholders.
• Provide PV training to internal stakeholders, such as clinical teams and new joiners.
• Leading PV audits and inspections and preparing responses to findings and observations.
• Oversee CAPA implementation.
• Perform organization level analysis for defects, incidents, CAPA, deviation.
• Participate in project planning meetings, retrospective meetings, risk management meetings and project closure meetings.
• Conduct Process trainings.

My Responsibilities:

• Processed safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
• Performed Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information.
• Ensure to meet the expected productivity, quality standards and delivery standards per project requirements.
• Identify quality problems, if any, and bring them to the attention of a senior team member.
• Mentoring new team members, if assigned by the Manager.
• Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.
• Willingness and aptitude to learn new skills across Safety service lines.

My Responsibilities:

• Managed health and safety calls, medical information requests and product complaints by either providing product information to consumers, end users and healthcare professionals or documenting their adverse event reports.
• Navigated intricacies of drug safety databases to process adverse event reports.
• Communicated with internal or external contacts to resolve issues related to case processing.
• Compared adverse event source documents against safety database screens for transcription and medical accuracy.
• Worked on solicited cases, individual patient cases, spontaneous cases, pregnancy cases, literature cases and legal cases.
• Participated in the triage process for incoming documents to ensure timely and effective medical and scientific evaluation of adverse event information.
• Determining initial/update status of incoming events.
• Coding AE and Products, writing narratives, Literature related activities as per internal/ project timelines.
• Evaluation of reported adverse events (serious and non-serious) from all sources.
• Evaluate causality, seriousness and listedness for all cases.
• Assess the need for follow up information and issue follow up requests for all cases and post queries in EDC and/or to affiliate.
• Perform weekly literature surveillance related activities.

My Responsibilities:

• Triaged and registered incoming Clinical trail Adverse Event Reports to determine seriousness for prioritization of daily workflow.
• Performed duplicate and database searches as necessary.
• Data entry of adverse events, medical history, concomitant medications into the ArisG and ARGUS database.
• Review of source documents such as physician's records and lab details for the case review.
• Preparation of case narratives in ARISG/ARGUS, always following the ICH and FDA guidelines in the process and medical writing.
• Identifying clinically relevant information missing from the case reports and facilitate its collection by preparing follow-up requests/letters.
• Submissions of CIOMS/MedWatch forms and serious cases to regulatory authorities including the FDA and EU.
• Assisting with preparation and review of regulatory reports.
• Enter preliminary and follow-up information from source documents into the global adverse event database ArisG.
• Maintain a log of source documents and other communications.

My Responsibilities:

• Call intake for pharmaceutical, dietary supplement and medical device products for both adverse event and product complaint reporting.
• Pharmacovigilance case processing including: Case assessment; Case follow-up activities and MedWatch preparation.
• Developed training materials, conducted training presentations and on-the-job-training for pharmacovigilance staff.
• Worked on transition team for safety database transfer from AERS to Argus, also familiar with the IRMS database.
• Completely and accurately documented calls.
• Managed toxicology calls by providing consumers with safety information and treatment advice following exposure to products.