Bioclinica is utilizing data and technology to enable more efficient trial conduct. We are looking at ways to reduce the size of the trials, provide greater clarity into the effect of the drug, and to reduce the amount of complexity in the trial. We do this by improving trial design and utilizing advanced analytics to identify patients who would be high responders for a particular clinical trial.
Post : Team Lead - ICSR Processing
Job Description
• Track, trend and evaluate adherence to Policies, SOPs, Supporting Documents, Work Instructions, guidance documents and contractual obligations for the management
• Analyse the results of the peer review and QC activities, along with quality issues that arise from Client queries
• Implementation of Corrective/Preventative action and Root Cause Analysis to minimize error from recurring. Proactive role in minimizing quality errors.
• Plan and attend regularly scheduled project meetings with team to discuss quality of work, overall performance, project specific issues and any policy changes
• Perform quality review and is responsible for liaising with the Director, Quality Assurance for the development of a Quality Management System (QMS)
• Preparation of Quality Plan
• Mechanism to identify quality issues, analyse trends and action taken as appropriate to continuously improve the quality and timelines of services provided.
• Quality delivery through a rigorous metrics-based approach
• Preparation of Quarterly QA report.
• Track, trend and evaluate adherence to Policies, SOPs, Supporting Documents, Work Instructions, guidance documents and contractual obligations for the management
• Analyse the results of the peer review and QC activities, along with quality issues that arise from Client queries
• Implementation of Corrective/Preventative action and Root Cause Analysis to minimize error from recurring. Proactive role in minimizing quality errors.
• Plan and attend regularly scheduled project meetings with team to discuss quality of work, overall performance, project specific issues and any policy changes
• Perform quality review and is responsible for liaising with the Director, Quality Assurance for the development of a Quality Management System (QMS)
• Preparation of Quality Plan
• Mechanism to identify quality issues, analyse trends and action taken as appropriate to continuously improve the quality and timelines of services provided.
• Quality delivery through a rigorous metrics-based approach
• Preparation of Quarterly QA report.
SPECIALIZED KNOWLEDGE AND SKILLS:
• Excellent understanding of Medical terminology and familiarity with principles of clinical assessment of AE in the context of international Pharmaceutical Industry
• Ability to discern when additional input is required to effectively address unique and/or complex situations
• Demonstrated computer literacy, particularly in use and management of relational databases as end users of the database. Strong skills in productivity, Organizational and time management to meet strict regulatory compliance goals
• Ability to achieve personal objectives while meeting departmental standards of performance.
• Excellent understanding of Medical terminology and familiarity with principles of clinical assessment of AE in the context of international Pharmaceutical Industry
• Ability to discern when additional input is required to effectively address unique and/or complex situations
• Demonstrated computer literacy, particularly in use and management of relational databases as end users of the database. Strong skills in productivity, Organizational and time management to meet strict regulatory compliance goals
• Ability to achieve personal objectives while meeting departmental standards of performance.
COMMUNICATION SKILLS:
• Requires a proactive approach and excellent written/oral communication and interpersonal skills.
• Strong interpersonal skills required to interact with clients, management, and peers effectively.
• Effective cross departmental communication.
• Ability to document and communicate problem/resolution and information/ action plans.
• Requires a proactive approach and excellent written/oral communication and interpersonal skills.
• Strong interpersonal skills required to interact with clients, management, and peers effectively.
• Effective cross departmental communication.
• Ability to document and communicate problem/resolution and information/ action plans.
DESIRED TECHNICAL SKILLS:
• Basic competence with medical and therapeutic terminology
• Knowledge of US and EU regulations and guidelines for Pharmacovigilance
• Basic competence with medical and therapeutic terminology
• Knowledge of US and EU regulations and guidelines for Pharmacovigilance
OTHER SKILLS:
• The ability to contribute to a team environment with a high degree of professionalism and skill.
• Demonstrate flexibility within a dynamic, fast-paced, cross-functional team. Demonstrated ability to complete multiple tasks concurrently and deliver results in a fast-paced environment.
• Ability to perform under stringent timelines.
• The ability to contribute to a team environment with a high degree of professionalism and skill.
• Demonstrate flexibility within a dynamic, fast-paced, cross-functional team. Demonstrated ability to complete multiple tasks concurrently and deliver results in a fast-paced environment.
• Ability to perform under stringent timelines.
COMPLIANCE:
• Awareness of organizational policies & procedures governing his/her job responsibilities.
• Awareness and compliance of QMS & ISMS policies & procedures and their impact at his/her job level.
• Should understand escalation matrix and escalate to the next level whenever incidents happen which are not in compliance with organizational, QMS & ISMS policies and procedures.
• Awareness of organizational policies & procedures governing his/her job responsibilities.
• Awareness and compliance of QMS & ISMS policies & procedures and their impact at his/her job level.
• Should understand escalation matrix and escalate to the next level whenever incidents happen which are not in compliance with organizational, QMS & ISMS policies and procedures.
Candidate Profile
Years of Experience: 3 to 4 Years of industry related experience
Education: MBBS / MD or B pharm / M pharm / MBA
Experience: More than 3 years of experience in Pharmacovigilance /Pharmaceutical / Clinical research professional.
Years of Experience: 3 to 4 Years of industry related experience
Education: MBBS / MD or B pharm / M pharm / MBA
Experience: More than 3 years of experience in Pharmacovigilance /Pharmaceutical / Clinical research professional.
Specialized Knowledge and Skills:
Subject Matter Expertise in Safety database
Must have good presentation skills and the ability to give presentations.
Knowledge of the Life Sciences Industry a plus.
Experience in entire drug development life cycle.
Relevant product and industry knowledge
Experience with relevant safety databases and software applications
Subject Matter Expertise in Safety database
Must have good presentation skills and the ability to give presentations.
Knowledge of the Life Sciences Industry a plus.
Experience in entire drug development life cycle.
Relevant product and industry knowledge
Experience with relevant safety databases and software applications
Communication skills:
Requires a proactive approach and excellent written/oral communication and interpersonal skills.
Strong interpersonal skills required to interact with clients, management, and peers effectively.
Effective cross-department communication.
Ability to document and communicate problem/resolution and information/action plans.
Requires a proactive approach and excellent written/oral communication and interpersonal skills.
Strong interpersonal skills required to interact with clients, management, and peers effectively.
Effective cross-department communication.
Ability to document and communicate problem/resolution and information/action plans.
Technical Skills:
Person should be familiar with MS Office tools/Data base and other applicable software.
Ability to educate/ train the team members as needed.
Maintaining Pharmacovigilance systems including global safety database.
Other Skills:
The ability to contribute to a team environment with a high degree of professionalism and skill. Demonstrated flexibility within a dynamic, fast-paced, cross-functional team. Demonstrated ability to complete multiple tasks concurrently and deliver results in a fast-paced environment. Ability to perform under stringent timelines.
Person should be familiar with MS Office tools/Data base and other applicable software.
Ability to educate/ train the team members as needed.
Maintaining Pharmacovigilance systems including global safety database.
Other Skills:
The ability to contribute to a team environment with a high degree of professionalism and skill. Demonstrated flexibility within a dynamic, fast-paced, cross-functional team. Demonstrated ability to complete multiple tasks concurrently and deliver results in a fast-paced environment. Ability to perform under stringent timelines.
Additional Information
Experience : 1 - 5+
Qualification : B.Pharm, M.Pharm
Location : Mysore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : ICSR Processing
End Date : 5th January, 2019
Experience : 1 - 5+
Qualification : B.Pharm, M.Pharm
Location : Mysore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : ICSR Processing
End Date : 5th January, 2019
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