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Quality Auditing Senior Analyst-Pharmacovigilance

5.00 to 8.00 Years   Bangalore   01 Feb, 2023
Accenture
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryIT - Software
Functional AreaBio Tech / R&D / Scientist
EmploymentTypeFull-time

Job Description

    Skill required: Pharmacovigilance - Pharmacovigilance & Drug Safety SurveillanceDesignation: Quality Governance ScientistQualifications: Bachelor in Physiotherapy/Bachelor of Dental Surgery/Bachelor of PharmacyYears of Experience: 5 to 8 yearsYou will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world s leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. 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 create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Internal audit Pharmacovigilance & Drug Safety Surveillance Quality Assurance (QA) Quality Management Risk and compliance Adaptable and flexible Agility for quick learning Detail orientation Problem-solving skills Risk management Roles and Responsibilities In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts,

Keyskills :
customer relationsreportingbasisaccountsresearchdata entrydrug safetylife sciencesstudy reportsinternal auditrisk managementproblem solvingclinical trials

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