Senior Associate, Safety Surveillance Physician

<p><strong>Primary Responsibilities:</strong></p> <p>The Safety Surveillance Physician (Std.) will implement and support further development of proactive and systematic product surveillance strategies, by performing activities such as, but not limited to:</p> <ul> <li>Performance of alert triage within pre-defined timelines, by conducting systematic reviews of cases and aggregate data in the safety databases and reviewing trends, as applicable, to identify potential safety signals.</li> <li>Performance of signal validation and support for signal evaluation through the review, analysis, interpretation, and summary of case and aggregate safety data from various sources such as<br>clinical, post marketing, observational studies, medical literature, health authority databases, and product quality databases.</li> <li>Assistance in the development and implementation of strategies for the surveillance of post-marketing data, as well as the development of product specific medical safety assessments.</li> <li>Participation as a member of the matrix teams to address product-specific safety issues.</li> <li>Support for the evaluation of novel and computer-assisted tools and methodologies for the analysis of safety data.</li> <li>Tracking of signal disposition and signal management activities in the relevant tracking tool.</li> <li>Support for maintenance of documentation relevant to signal detection and management activities.</li> </ul> <p><strong>Secondary Responsibilities:</strong></p> <ul> <li>Effectively organize work to complete the assigned tasks to meet deadlines.</li> <li>Ensure the assigned tasks are delivered 100% on time or before, as per project SLA.</li> <li>Demonstrate Quality of Work &amp; Commitment through excellence in work, ensure correctness and completeness in deliverables with minimum OR no re-work.</li> <li>Support in review of work done by peer teammates, on need basis.</li> <li>Alerts and escalates to senior members as required, whenever project deliverable risks are visualized, OR issues encountered impacting the delivery schedule.</li> <li>Ensure error-free and acceptable quality in assigned deliverables.</li> <li>Responsible for ensuring training compliance and timesheet compliance.</li> <li>Ensure that all assigned goals [e.g. utilization and efficiency] are met as per set standards for the performance year.</li> <li>Be aware of and comply with the QMS/ ISMS &amp; PIMS Policy.</li> <li>Report any potential or actual Security Breaches to the regional and/or global DPO &amp; Security Incidents to CISO/ applicable distribution list.</li> <li>Contribute towards the achievement of Quality Objectives.</li> </ul> <p><strong>Candidate Profile:</strong></p> <ul> <li>Board-certified Medical Physician</li> <li>Technical skills: Ability to analyze, interpret, and present complex data in a concise and understandable scientific manner, both orally and in written format.</li> <li>Attention to detail: Diligence in record-keeping and records organization, ability to manage a high workload and critical issues, computer-literate and proficient in MS Office applications.</li> <li>Interpersonal skills: team player, displays initiative, strong communication, and presentation skills</li> <li>Internal and external networking skills, strong collaborative and interpersonal skills, results-oriented and ability to independently create and deliver, ability to thrive in a global, cross-functional environment.</li> <li>Minimum of 3 to 5 years of relevant experience in identified functional domain/ business workstream</li> </ul>