Senior Analyst-Pharmacovigilance

  Pharmacovigilance

Job title: Senior Analyst-Pharmacovigilance

Company: Accenture

Job description: Designation: Senior Analyst About Accenture Operations In today’s business environment, growth isn’t just about building value-it’s fundamental to long-term business survival. So how do organizations sustain themselves? The key is a new -one that’s

Designation: Senior Analyst About Accenture Operations In today’s business environment, growth isn’t just about building value-it’s fundamental to long-term business survival. So how do organizations sustain themselves The key is a new -one that’s anchored around the customer and propelled by intelligence to deliver exceptional experiences across the enterprise at speed and at scale. You will deliver breakthrough business outcomes for clients-by harnessing talent, data and intelligence to revolutionize their operating models. Operations is one of four services that make up one Accenture -the others are Strategy and Consulting, Interactive and Technology. Visit us at What would you do You 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: Ability to establish strong client relationship Ability to work well in a team Ability to manage multiple stakeholders Ability to meet deadlines Roles and Responsibilities In this role, you need to analyze and solve increasingly complex problems Your day to day interactions is 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 instructions on new assignments You will need to consistently seek and provide meaningful and actionable feedback in all interactions You will be expected to be constantly on the lookout for ways to enhance value for your respective stakeholders/clients Decisions that are made by you will impact your work and may impact the work of others You would be an individual contributor and/or oversee a small work effort and/or team. Please note this role may require you to work in rotational shifts.

Expected salary:

Location: Bangalore, Karnataka

Job date: Mon, 21 Feb 2022 23:00:34 GMT

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