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| Job Location | Mysore |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Pharma / Biotech |
| Functional Area | General / Other Software |
| EmploymentType | Full-time |
Job Title : Associate Team Lead- Drug safetyLocation: Mysore , IndiaYears of Experience: 3 to 4Years of industry related experience in Pharmacovigilance / PharmaceuticalEducation: BPharm / Mpharm / Pharm D and MBAEssential Duties and Responsibilities:As a Associate Team Lead:Supervision and coordination of following activities:Lead and manage the projectsSupervise all project related activities.Communicate between the Project Manager and the team.Record , maintain and track the metrics for both team members and project performance.Review and evaluate AE case information to determine required action based on and following internal policies and procedures.Process current incoming cases in order to meet timelines.Provide guidance for Data entry.Following up with sites regarding outstanding queries.Follow-up on reconciliation discrepancies.Follow departmental AE workflow procedures.Train and mentor new team members as per requirements of the project.Delegate tasks and responsibilities to appropriate personnelIdentify and resolve issues and conflicts within the project teamAct as guide , coach and counselor for the teamOther responsibilities:Following up with sites regarding outstanding queries and reconciliation of discrepanciesClosure and deletion of casesFollow departmental AE workflow proceduresOversee , mentor and guide the activities of the Drug Safety and Senior Drug Safety AssociatesHigh level of proficiency at all workflow tasksPerform any other drug safety related activities as assignedSpecialized Knowledge and Skills:Subject Matter Expertise in Safety databaseMust 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 knowledgeExperience with relevant safety databases and software applicationsCommunication 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.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.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.Working Conditions: Normal office environment.Hours:Standard Hours 40 hours per week , one hour lunch , Monday Friday. Additional hours as needed.Willing to work in shifts as and when neededBioclinica is an Equal Opportunity Employer / Committed to Diversity,
Keyskills :
msofficetools msoffice dataentry drugsafety lifesciences drugdevelopment oliciesprocedures subjectmatterexpertise stronginterpersonalskills followingup alcommunication presentationskills interp