Highlights:Experienced pharmacovigilance professional with a proven track record in delivering multiple projects for pharma company. Currently, working on two pharmacovigilance projects (EU). With extensive experience in end-to-end delivery of PV projects, I have worked upon various domains of PV including ICSR processing and data evaluation. Can collaborate with client team, project team, and ultimately deliver client focused results on time and with complete quality.

Skills:Communication skills, FDA, ICH, FDA, Health canada, Regulatory authority, EMA

Goal:Seeking an opportunity in a company where I can use my experience and education to help the company meet and surpass its goals.

Drug Safety Associate II Sep/2021 - current
Bioclinica India Pvt Ltd, Ahmedabad, Gujarat India
Industry: Pharma and Health care
ICSR Review Meetings and training to new hires Quality review of safety data Literature evaluation Safety reporting / spontaneous reporting
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Pharmacovigilance Associate Aug/2019 - Aug/2021
Apcer Lifescience, Ahmedabad, Gujarat India
Industry: Healthcare and lifescience
Technical skills: - MedDRA browser - ARGUS Database (version 8.1.2) - ArisG (version 7) Processing of cases of sources: - Literature, Business Partner, Spontaneous, Regulatory, Data Migration projects, MLM. (reportable and nonreportable as per EU and outside EU territory. Embase evaluation
Case management activities which includes: - Conducted drug safety assessments for adverse drug reaction reports originating from clinical trials, literature and medicalinquiries. - Performed triagesfor all types of safety reports, handled safety mailbox and was responsible for import for E2B R3 reports originating from Eudravigilance. - Evaluated ICSRs for validity and consistency Case management activities which includes: - Conducted drug safety assessments for adverse drug reaction reports originating from clinical trials, literature and medicalinquiries. - Performed triagesfor all types of safety reports, handled safety mailbox and was responsible for import for E2B R3 reports originating from Eudravigilance. - Evaluated ICSRs for validity and consistency Case management activities which includes: - Conducted drug safety assessments for adverse drug reaction reports originating from clinical trials, literature and medicalinquiries. - Performed triagesfor all types of safety reports, handled safety mailbox and was responsible for import for E2B R3 reports originating from Eudravigilance. - Evaluated ICSRs for validity and consistency Quality Check of lCSRs (as applicable) in Pharmacovigilance database: - Performed Peer review (MedDRA Coding, narrative, report scheduling etc.) for all types of cases processed and ensured their 100% quality review of all the data entered in safety database for completeness and accuracy with reference to source documents as per applicable SOPs. Met compliance with internal standards and external regulations. - Trained the data entry team on narrative writing, Causality Assessment, MedDRA coding and provided quality feedback to DE team for case findings. - Screening, evaluation and review of literature articles for identification of valid/potential lCSRs for processing - Ensured all sponsor and regulatory timelines are met 100% for processing and safety reporting. - Assisted in ensuring the completion of all departmental project activities accurately to meet the regulatoryrequirements. - Mentored drug safety associates in case processing according to project- specific guidelines (Data Migration Cases). - Attended project team meetings and teleconferences on monthly basis. - Execution of Company Standard Operating Procedures - Management of Compliance with the Company Standard OperatingProcedures and regulatory requirements.--

SNMPPC Aug/2013 - May/2017
Ahmedabad, Gujarat, India
Degree: Bachelor's Degree
Major:Bachelor's of Pharmacy
Bachelor's of Pharmacy

Happy Patel