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| Job Location | Mumbai City |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | IT - Software |
| Functional Area | Sales / BD |
| EmploymentType | Full-time |
Associate - Regulatory AffairWe are inviting applications for the role of Associate, Regulatory affairs! In this role, you will be responsible to work on deadlines, in a fairly high pressure business environment while being a good team member. You should have the ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy.ResponsibilitiesThe Role demands for a highly qualified professional who should have Regulatory Data safety experience under regulatory affairs domain. Associate will be responsible for activities related to Preparing and sorting documents for safety data entry. Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements. Entering data into database software and checking to ensure the accuracy of the safety data that has been entered in the software within the established timeframes. To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and supervising incoming - Adverse Events(AE)/endpoint information Resolving initial/update status of incoming events Resolving discrepancies in information and acquiring further information for incomplete documents. Crafting, maintaining and tracking cases as applicable to the project plan. Through daily case prioritization activities, reports are completed within the established timeframes to ensure compliance with internal, business partner, and regulatory agency reporting requirements worldwide. Evaluation of the need for expedited reporting to Health Authorities / partners of a client concerned, including reporting timelines Preparation of standard reporting forms (e.g., CIOMS I / MedWatch Forms and XML files) Preparation and sending of follow up requests The ICSR search/retrieval process from the EVWEB database and company/non-company assessment for cases Screening scientific literature by using the internal search mechanism and/or by making use of external tools and providers Classification of references of safety-relevant publications Data entry of literature reports into the safety database Preparation of standard reporting forms (e.g., CIOMS I / MedWatch Forms and XML files) Downloading, reviewing and sharing of client specific ICSRs from MLM service of EMA Coding of the events/drugs using MedDRA/CCDS .Minimum Qualifications Bachelor s degree in pharma / Science Strong financial analytical skills and problem solving skills. Effective communicate in writing and verbally to senior management. Experience in balancing customer facing role and work assessments. Self-starter and have analytical, prioritization skills Ability to balance customer governance meetingsPreferred qualifications Able to further working relationships with the team, peers and clients, scheduling flexibility required Overall candidate should have decision-making, research and analytics approach and in numbers. Good people and customer handling skills. Effective communication and interpersonal skill.,
Keyskills :
standard operating proceduresdata entrypostingmail sortinghigh pressureprocess safetycustomer focusproblem solvingcontent strategy