Headline

Senior Pharmacovigilance Officer

Location

Meerut

Work experience

Intern at Swega Laboratories

Pharmacovigilance Assistant at Qinecsa Solutions, Oct 2020 - Aug 2022 · 1 yr 11 mos, Mysore, Karnataka, India

Drug Safety Specialist at Bioclinica, Oct 2020 - Aug 2022 · 1 yr 11 mos, Safety Narrative Writing for Serious and Non-serious cases including MedWatch (FDA 3500A) and CIOMS forms for domestic and international cases. Performing cases related to Regulatory Authorities, splitting of cases, At-risk scenarios and Lack of efficacy. Whole Case Processing: Product coding, Event assessment, Seriousness criteria, Narrative writing and conducting all the required follow-up activities as required in the ARGUS safety database. Coding of adverse events, product indications, lab data, and medical histories etc. using MedDRA dictionary. Coding of Products i.e. both suspect and concomitant medications using CDD and WHO drug dictionary. Analyze different types of AE reporting forms from different sources. Assessment of case reports for case validation (valid/invalid cases) and seriousness. Creating, generating, and assigning follow-up letters in the case, as appropriate, US-NDA Reporting, PQC filling, DCA, STQ etc. Processing, coding, and submitting serious and non-serious adverse event reports for spontaneous and sponsored studies, in compliance with global regulations and compliance timelines. Performing Nullification and merging of Potential Duplicate cases. Communicated daily with client and management staff to ensure timely completion of tasks and supported established departmental objectives. Compilation of data on everyday basis so as to maintain a daily track record.

Drug Safety Associate at Wipro, Apr 2017 - Oct 2020 · 3 yrs 7 mos

Education

M.Pharma - Pharmacy, Uttar pradesh technical university

B.Pharma - Pharmacy, Uttar pradesh technical university