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| Job Location | Delhi |
| Education | Not Mentioned |
| Salary | Rs 4.5 - 7 Lakh/Yr |
| Industry | Medical / Healthcare |
| Functional Area | Allied Health Services |
| EmploymentType | Full-time |
Roles and Responsibilities: To ensure compliance with global and local procedural documents and local implementation ofClient and TCS Patient Safety objectives, policies, procedures and processes. To assist physician in maintaining up to date knowledge of the client products assigned with focuson the safety perspective. This includes but is not limited to pharmacology, indications, safetyand efficacy aspects and could potentially include clinical studies and epidemiological analyses. To review clients surveillance strategy document and provide written confirmation verifying itsunderstanding of changes. To review aggregate case reports from Client designated safety database using relevant ISsystems. To review and assess literature bulletins and published meeting abstracts in accordance withbusiness search strategy, using relevant IS systems. To identify safety signals from routine review of cumulative safety data and conduct initialevaluation of those signals and document outcome according to client specified criteria andrequirements. To document potential signal and related information in the signal tracking tool and maintainsurveillance action log up to date. To notify business surveillance team of any safety signal that it has detected that may requireurgent evaluation and action. To prepare, summarize, evaluate and document routine pre-SERM (Safety Evaluation ReviewMeeting) safety outputs from business dedicated safety database, dedicated external databases(FDA AERS, WHO Vigibase) and the published literature. To participate in routine and ad-hoc team and project related meetings between Business andTCS like Handover Meeting, Surveillance Meeting, and Safety Management Team Meeting. To prepare training material, conduct and assess periodic and need based trainings as and whenrequired. To provide ongoing training on the updated surveillance strategy document, routine signalmanagement requirements, product safety profiles and updated safety signal detection criteriafor new hires. To participate in conducting gap analysis, and identify the remedial actions for the improvementof quality of deliverables as and when required. To provide regular work update to lead-safety surveillance.Requirement: Academic and Professional Qualification: Healthcare professional (B.Pharm, M. Pharm, PhD, Life sciences Post-graduate) with 2-5years of Pharmacovigilance experience in Pharmaceutical Company or Contract ResearchOrganization (CRO) including safety surveillance or signal detection activities. High level of medical competence, with an ability to balance this with industry standardsto achieve business goals.Experience: Knowledge of drug safety & clinical development and ICH/GCP principles Good knowledge of pharmacovigilance practices, particularly in relation to signaldetection and evaluation. Good knowledge of global Pharmacovigilance regulatory requirements. Excellent written and verbal communication skills and ability to present and criticallydiscuss clinical data in both internal and external discussions with client. Ability to evaluate, interpret and synthesize scientific data (analytical thinking). Skills required: Computer Literate ( good knowledge of MS Office) Good working knowledge of safety database Sound understanding of the Drug Safety and Regulatory process. Good problem solving and decision making skills.Others: Capability to lead by motivation and example. Ability to prioritize and organize. Attention to detail. Excellent interpersonal and communication skills.
Keyskills :
life sciencestraining materialverbal communicationsowproduct safetyclinical developmentgap analysissearch strategycommunication skillssignal detectionclinical datasoundcomputer literateproblem solvingpharmacovigilancedrug safetypatient