
Timeline
About me
Regulatory affairs officer
Education

Dublin city university
2021 - 2022Msc in bioprocess engineering pharmaceutical sciences
Nehru college of pharmacy, pambady
2013 - 2019Doctor of pharmacy - pharmd doctor of pharmacy
Experience

P k das institute of medical sciences
Sept 2017 - Aug 2018Clinical pharmacy internship (pharm d intern)Drug therapy monitoring, ADR monitoring• Handling Medical Literature and drug databases: Lexicomp ,Micromedex, Medline and Medscape• Assess the status of the patient’s health problems and determine whether the prescribedmedications are optimally meeting the patient’s needs and goals of care.Evaluate the appropriateness and effectiveness of the patient’s medications.• Drug interaction monitoring• Skilled and trained in providing Individualized therapeutic management and pharmaco-therapeuticplanning for optimizing patient’s health outcome.• Performing the Clinical review, therapeutic drug monitoring and adverse drug reaction Management.• Updating physicians about recent advances in the pharma-industry, about new drug arrivals andother pharmaco-therapeutic topics.• Excellent and skilled clinical pharmacist in providing drug information queries.• Patient counseling and advice on individual patient management. Show less

Merck
Nov 2018 - Aug 2021Pharmacovigilance associatePerform end-to-end pharmacovigilance lifecycle activities, including but not limited to Intake, triaging, ADR coding, risk criticality assessment, ensuring accurate/holistic investigation, and review and closure. Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements. Pro-actively involved in other workflow responsibilities for the assigned project as directedby Operations team Lead or Manager. Reviews and updates documentation of the reporting processes, recommending modification as appropriate. Perform safety operations including but not limited to collecting and tracking incoming Adverse Events (AE)/endpoint information; determining initial/update status of incoming events; book-in, triage, case processingand quality review in clinical trial, post marketing and legal cases. Monitored deliverables for quality and adherence to regulatory reporting timeline requirements. Root cause analysis of internal and customer questions and engagement in continuous improvement activities as required. Co-ordinate in development of SOPs and working guidelines for maintaining high quality standards in the workand to comply with regulations. Provides technical solution for quality improvement, and process excellence. Prepares timely responses to customer enquiries ensuring compliance against protocol requirements.Actively participates in Continuous Improvement processes within the pharmacovigilance department and workscross functionally with clinical, regulatory, quality assurance and data management teams to ensure efficient processes and best practice. Meeting up quality and productivity, deliverables as per project requirements and timelines; attend project team meetings and provide feedback to operations managers on any challenges/issues or successes. Show less

Gala
Sept 2021 - Jan 2022Sales associate-Assisted customers in heading up with their demands.-Maintained highly efficient workflow to ensure on-time order delivery. -Applied collaborative communication skills to interface with customers in resolving sale services and ensuring a satisfactory experience.

Adrian dunne pharmacy
Jan 2022 - Nov 2022Intern pharmacist-Responsible for dispensing and preparing prescriptions. -Providing a high standard in Customer Service-Ensuring efficient stock control & ethical ordering-Ensuring prescription control-Full responsibility for completion of end of month claims -Full understanding of reject and reclaims books-Completion of all necessary paperwork-Provide experience to help drive O.T.C Sales-Provide experience when reviewing KPI’s -Responsible for dispensary house keeping-Provide counselling to patients regarding the medications prescribed-Blister packaging preparations and auditing. Show less

Nibrt national institute for bioprocessing research and training
Feb 2022 - Mar 2022Internship traineeGained hands-on training in NIBRT that operates under Current Good Manufacturing Practices(cGMP) on* Sterile filling, Grade A/B Clean-room housekeeping, personal hygiene and gowning requirements* Steam Sterilization required for bioreactors* CIP/SIP process involved in a biopharmaceutical facility* P&ID analysis of process equipment * Commissioning and qualification of biopharmaceutical facilities * Ultrafiltration and diafiltration* Biopharmaceutical facility layout

Medtronic
Nov 2022 - Jan 2024Qualiy associate
Clonmel healthcare
Feb 2024 - nowRegulatory affairs officer
Licenses & Certifications

Pharmacist
Kerala pharmacy councilSept 2019- View certificate

Good clinical practice ich gcp for clinical research
UdemySept 2021
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