Inventiv health hiring Sr. Drug Safety Physicians "A"

 Sr. Drug Safety Physicians

inVentiv International Pharma Services Pvt. Ltd

3 - 5 yrs

Hyderabad / Secunderabad , Pune

Job Description

Responsibilities
Medical review of adverse events reported to investigational and marketed products including identification of event/s, confirmation of seriousness, ensure that events are coded and mapped to the appropriate terms in MedDRA, provide assessment of expectedness per reference safety information, assessment of causality, review of narrative for chronology and medical content and provide medical evaluation comment.
Ensure that appropriate medical interpretation and consistency are applied to adverse event case assessment.
Ensure regulatory compliance with respect to the evaluation, reporting and surveillance of safety information.
Identify, communicate, and effectively manage potential safety issues.
Provide medical safety analysis and interpretation for periodic safety aggregate reports (e.g. DSUR, PSUR/PBRER, PADER, bridging reports, and other relevant aggregate report/analyses).
Interact with clients safety/medical personnel as appropriate to ensure above.
Maintain a working knowledge of projects in the functional area for which inVentiv Health Clinical safety is responsible for safety reporting.
Stay abreast of clinical and drug development information relevant to contracted programs by review of literature and by maintaining training.
Serve as a mentor for other internal safety staff including case processing staff.

Company Profile:

inVentiv International Pharma Services Pvt. Ltd

PharmaNet/i3 is recognized as a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. Our expertise includes therapeutically specialized capabilities for Phase I-IV clinical development, bioanalytical services, and strategic resourcing from a single clinical professional to an entire functional team (FSP).

We seek individuals with a desire to excel in their fields, pursue excellence, and develop intelligent solutions by applying their knowledge and experience. Our employees focus on meeting our clients' requirements, work in a culture of mutual respect, and demonstrate a commitment to quality in everything they do. PharmaNet/i3 employees are empowered to think independently, be accountable, make decisions quickly, and use the resources of our global organization on our customers' behalf.

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Novartis Healthcare Jobs for Pharmacovigilance "A"

Pharmacovigilance Data Manager

Novartis Healthcare Pvt. Ltd.

3 - 5 yrs

Hyderabad / Secunderabad

Job Description

 

- To retrieve data and prepare outputs from the Pharmacovigilance database to support the analysis of drug safety related tasks. - Uses their experience of pharmacovigilance data management to mentor and train other data managers. - Identify process improvements and lead data management related activities.

Major Accountabilities: Support DS&E customers or other external line units by providing them with retrieved data from the Pharmacovigilance database. Understand and translate data retrieval need into query request, create query criteria, retrieve data from the Pharmacovigilance database and provide the results to DS&E staff or external line functions. Generate regulatory reports, standard reports, tabulations and retrievals in preparation for regulatory submission Perform QC check on data retrieved; Identify errors/inconsistencies in outputs and resolves them or initiates their resolution. Train and mentor new Pharmacovigilance Data Management personnel as appropriate. To Provide Input and review of database design, validation checks and necessary reports to ensure high quality and consistent data during retrievals. Identifies opportunities for improvement of DS&E business processes and proposes and implement new solutions. Assist Department Head in defining Pharmacovigilance data management strategy and guidelines in order to establish common rules for assessing adverse event reports. Support testing and validation processes in DS&E IT projects.

Company Profile:

Novartis Healthcare Pvt. Ltd.

A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes us one of the most rewarding employers in our field. 

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