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| Job Location | Chennai |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | IT - Software |
| Functional Area | Risk / Underwriting |
| EmploymentType | Full-time |
Skill required: Pharmacovigilance - Clinical & Regulatory WritingDesignation: AnalystQualifications: Bachelor in Physiotherapy/Bachelor of Dental Surgery/Bachelor of Pharmacy/BSc. NursingYears of Experience: 3-5 yearsYou will be aligned with our Pharmaceuticals Processes vertical and help us with the processes to collect, monitor, research, assess and evaluate information on the adverse effects of medication with a view to identifying new information about hazards associated with medicines and consequently, prevent harm to patients. It also deals with the reviewing and resolving of discrepancies identified by the system or through manual checks as per guidelines. Employees under this span can also be responsible for a number of activities related to the design, development, and maintenance of Clinical Database objects.You will be part of a dynamic Pharmacovigilance team with array of capabilities ranging from detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem following Good Pharmacovigilance Practice (GVP) per client SOPs and applicable global regulatory requirements (Individual Case Safety Reports) to working on various aspects of Aggregate reports such as planning, authoring, reviewing and publishing of PBRER, PSUR, DSUR, PADER, Addendum to clinical overview (AdCO), Risk Management Plan (RMP), Signal detection and validation reports (SDVR), Cosmetovigilance Safety Reports (CoSR). The Pharmacovigilance team is also responsible for authoring and reviewing clinical documents such Protocols and amendment, Investigator Brochure, Clinical Study Reports (CSR), Synoptic/Abbreviated CSR, Safety Narratives, Clinical Overview/abbreviated Clinical Overview.In this role, you will be expected to produce variety of clinical documents throughout the lifecycle of a (potential) treatment, starting with describing and reporting data from clinical trials, through to preparing regulatory submission documents including post approval reports.What are we looking for We are looking for individuals who have the following skillset:
Keyskills :
study reportsrisk managementclinical trialsbusiness processdigital conversionvalidation reportsprofessional servicesregulatory requirementsclinical study