Skill required: Pharmacovigilance Operations - Safety Writing
Designation: Pharmacovigilance Services Sr Analyst
Qualifications:Master of Pharmacy
Years of Experience:3 to 5 years
About Accenture
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What would you do Prepare and review risk management plan (RMP) and any adhoc reports requested by client. Planning pharmacovigilance activities to characterize and quantify chemically relevant risk and to identify new adverse reactions. Planning and implementation of risk minimization measures, including the evaluation of the effectiveness of these activities. Facilitate and conduct safety review meeting as and when required and liaise with risk minimization physician on new RMP request or update to existing RMP based on health authority request, update in safety profile or any other reason. Liaise with relevant internal and client stakeholders for the inputs required for RMP. Initiate, organize, and lead the Call for Information (CFI) meeting/ kick-off meeting (KOM), and other necessary ad hoc meetings with agreed contributors. Prepare meeting minutes and distribute final m Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. Manage and develop individual case narratives describing adverse events for inclusion in regulatory submissions and safety reports for completed/interim clinical study reports.
What are we looking for
- RMP end to end writing and reviewing experience which includes Innovator and Biosimilar molecules The person should have good knowledge of RMP to draft full application and generic both. The communication skills, writing skills should be good 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, Master of Pharmacy
