Pharmacovigilance Analyst Job @ Accenture – M Pharma Apply
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Job Title: Analyst-Pharmacovigilance
Job Location: Bengaluru
JOB NO. 183834
Skill required: Pharmacovigilance – Clinical & Regulatory Writing
Qualifications: Master of Pharmacy
Years of Experience: 3-5 years
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 reviewing and resolving discrepancies identified by the system or through manual checks 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 as Protocols and amendments, Investigator brochures, Clinical Study Reports (CSR), Synoptic/Abbreviated CSR, Safety Narratives, and 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 they looking for?
They are looking for individuals who have the following skillset:
- Adaptable and flexible
- Ability to perform under pressure
- Ability to establish a strong client relationship
- Agility for quick learning
Roles and Responsibilities
- In this role, you are required to analyze and solve lower-complexity problems
- Your day-to-day interaction is with peers within Accenture before updating supervisors
- You may have limited exposure with clients and/or Accenture management
- You will be given moderate-level instructions on daily work tasks and detailed instructions on new assignments
- You will need to be well versed with basic statistics and terms involved in the day-to-day business and use it while discussing with stakeholders
- You will be expected to constantly be on the lookout for ways to enhance value for your respective stakeholders/clients
- The decisions you make impact your work and may impact the work of others
- You will be an individual contributor as a part of a team with a focused scope of work.
Click Here To Apply Online
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