Senior Associate, Safety Surveillance Physician

Primary Responsibilities:

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:

• 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.

• 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
clinical, post marketing, observational studies, medical literature, health authority databases, and product quality databases.

• 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.

• Participation as a member of the matrix teams to address product-specific safety issues.

• Support for the evaluation of novel and computer-assisted tools and methodologies for the analysis of safety data.

• Tracking of signal disposition and signal management activities in the relevant tracking tool.

• Support for maintenance of documentation relevant to signal detection and management activities.

Secondary Responsibilities:

• Effectively organize work to complete the assigned tasks to meet deadlines.

• Ensure the assigned tasks are delivered 100% on time or before, as per project SLA.

• Demonstrate Quality of Work & Commitment through excellence in work, ensure correctness and completeness in deliverables with minimum OR no re-work.

• Support in review of work done by peer teammates, on need basis.

• Alerts and escalates to senior members as required, whenever project deliverable risks are visualized, OR issues encountered impacting the delivery schedule.

• Ensure error-free and acceptable quality in assigned deliverables.

• Responsible for ensuring training compliance and timesheet compliance.

• Ensure that all assigned goals [e.g. utilization and efficiency] are met as per set standards for the performance year.

• Be aware of and comply with the QMS/ ISMS & PIMS Policy.

• Report any potential or actual Security Breaches to the regional and/or global DPO & Security Incidents to CISO/ applicable distribution list.

• Contribute towards the achievement of Quality Objectives.

Candidate Profile:

• Board-certified Medical Physician

• Technical skills: Ability to analyze, interpret, and present complex data in a concise and understandable scientific manner, both orally and in written format.

• 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.

• Interpersonal skills: team player, displays initiative, strong communication, and presentation skills

• 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.

• Minimum of 3 to 5 years of relevant experience in identified functional domain/ business workstream