Senior Drug Safety Physician

Title: Senior Drug Safety Physician

KA, IN

Job Description

Looking to jump-start your careerWe understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegene s high-speed growth.We are purpose-driven. We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work.

Must Have

PRINCIPAL RESPONSIBILITIES:

Responsible for medical review of ICSRs for accuracy, medical relevance, and overall consistency of information captured in the safety database against all the applicable supporting documents as per the client requirement

Evaluate adverse events (AE) report for seriousness, listedness and ensures that all medically relevant information from the source documents is included

Assessment of reported AE and serious adverse events (SAE) providing company causality assessment utilizing clinical and global introspection methodologies aligned with global regulations.

Reviews the case narrative, coding, product/Indication, labeling in accordance with the respective reference safety documents, causality and medical history for medical completeness, accuracy, and overall medical content.

Provide medical sign off on the case.

Perform line listing review of non-serious cases and evaluates the coding and labelling and confirm the events are evaluated correctly

Perform unblinding activities as applicable

Ensure appropriate follow-up questions/questionnaires are sent out based on the case.

Perform Literature Surveillance when required

Medical review of Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements

Provide aggregate reviews of safety information, including but not limited to clinical data, post marketing, and literature review

Tracking of inconsistencies on activities performed by data entry and QC reviewer as per the checklist and provide unbiased feedback, suggestions, points of improvement for attaining quality standards as per client expectations

Responsible for following international pharmacovigilance regulations, company and department SOPs and department and function working practices.

Contribute to pharmacovigilance and risk management planning for designated products by preparation of safety surveillance strategy and tracking and evaluating potential issues.

Review safety assessments, risk/benefits evaluations, provide inputs and value add from medical perspective at all stages of safety

Review, author and update standard operating procedures (SOP) and support in global initiatives for ensuring enhanced quality and compliance

Communicate the observations to the applicable stakeholders and ensure the appropriate root cause analysis (RCA)/corrective action and preventive action (CAPA)

Ensures follow up information is requested on relevant reports

Present QA data to the responsible internal stakeholders in an appropriate forum as required

Attend all the internal trainings and client trainings and ensure compliance with applicable guidelines

Attend all the Governance and team meetings as required and appropriate

Your impact: Must have:

Cognitive abilities including verbal reasoning, attention to detail, critical thinking, scientific accuracy, and analytical ability

Ability to understand the purpose and requirements of a project

Good comprehension skills

Good communication and interpersonal skills

Drive quality and ensure team meets deadlines and commitments

Excellent mentoring and training skills Knowledge of disease pathology and physiology, pharmacology and therapeutics.

Familiarity with pharmaceutical industry principles of drug development and pharmacovigilance is preferred but not required.

Very good understanding and track record in pharmacovigilance that can be applied and executed

Sound knowledge in pharmacovigilance safety database and compliance activities

Good to have