The Clinical Safety function provides support to the clinical science & operations team and global pharmacovigilance department with regards to safety reporting in clinical study activities. Supports the review of drug safety data, and provides administrative assistance. Is responsible for assuring compliance with SOPs, ICH guidelines, and FDA regulations for the monitoring and reporting of adverse events and timely process of serious adverse event reports for the planning, implementation and monitoring of clinical studies in all phases of drug development. It supports clinical study teams with the implementation and management of clinical trials, including preparation and maintenance of safety related study documents, communication with CRO and clinical sites.
Responsible for documentation, follow-up and evaluation of adverse events in clinical trials.
Responsible for review of adverse events coding and concomitant medications using MedDRA classification.
Review and/or write and maintain case narrative document for all Serious Adverse Events. Insure the uniform and timely processing of serious adverse event reports. Maintain all clinical safety files.
Maintain trackers and ensure SAE timelines compliance (for both internal reporting and regulatory reporting timelines).
Assist in generating safety related reports for internal/external review and/or submission.
Insure timely reporting of adverse events to regulatory agencies.
Responsible for review of safety data (e.g. laboratory results, AE/SAE listings, and safety related CRFs) to assure accuracy and consistency.
Maintain high state of knowledge of adverse event regulations, guidelines and standards relating to adverse reaction surveillance.
KEY RESULT AREAS AND KEY PERFORMANCE INDICATORS
Assist in the preparation and execution of safety documentation for clinical trials (e.g. SAE management plans, SAE reconciliation plans, IB, Protocol, ASR/DSUR).
Attend drug safety meetings and assist the Lead Safety Physician in providing safety updates to the R&D colleagues and study sites as appropriate.
To attend project/study meetings and assist study members in delivering study updates and provide support for investigator meetings.
Assist drug safety team members with adherence to global and local Standard Operating Procedures and the respective Working Instructions during the clinical trial activities. Assist with renewal, generation and training of existing or new SOPs/Working Instructions/Forms.
Assist clinical operations team members with adherence to global and local Standard Operating Procedures and the necessary Working Instructions during the clinical trial. Provide assistance in the renewal, generation and training of existing or new SOP/Working Instructions/Forms.
Assist in reconciliation of clinical and safety databases. Collaborate with clinical research associates and data managers to resolve safety related issues.
Review and resolve discrepancies in clinical data at clinical sites and central laboratories via query process
Support clinical study teams with the implementation and management of clinical trials including preparation and maintenance of study documents (e.g. protocol, IB, informed consents, case report forms, instruction manuals, clinical study reports, and monitoring tools).
Maintain effective communication with CRO and clinical sites to disseminate study information.
EDUCATION AND EXPERIENCE
Requires a minimum of bachelors degree in medicine
Minimum of 3 to 4 years in drug safety or equivalent experience.
Requires strong knowledge of FDA regulations, and GCP and ICH guidelines related to AE/SAE reporting in clinical trials.
At least: 3 years Experience in pharmacovigilance
Role Category: R&D
Role: Clinical Research Manager
Employment Type: Permanent Job, Full Time
Education:UG -MBBS – Medicine
Sun Pharmaceutical Industries Ltd
Sun Pharma an international,specialty pharmaceutical company headquartered in India with a global manufacturing network across 25 countries. We manufacture and market a large basket of pharmaceutical formulations as branded generics & generics in India, US and across the world. Our leadership is approachable, encourages transparency & strong work ethics to ensure that people get the best opportunities to learn and grow. We encourage our employees to challenge themselves for highest level of performance through greater bandwidth of work responsibilities and growth opportunities.
Apply to us if you wish to be part of Sun Pharma growth story.
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