Highlights:Analytical and results oriented Senior Drug Safety Associate with over 4 years' of experience collaborating as a strong team player to uncover and address pharmaceutical safety issues. Great communication, organization, and time management abilities.

Skills:case processing, quality review of cases, medical writing, drug safety, pharmacovigilance, AOSE writing, MedDRA coding

Goal:To work as a drug safety associate in an organization and examine drug trials closely for safety, maintain records of experiments, perform research, and establish safety guidelines

Membership:Registered Pharmacist, Kerala State Pharmacy Council

Certification:Good Clinical Practice Certificate from Barnett International

Honor:Underwent onsite training at client location Horsham, USA in the aspects of pharmacovigilance ofa newly launched oncology product and leading a group of 40 associates in current organization. Received consolation prize for poster presentation on topic “Chronotherapy of antihypertensive drugs” at International seminar on “Pharmacovigilance and Clinical Research; Regulatory and Ethical concerns around the globe” Organized by Pharmanext, Goa. Subject matter expert in Clinical trial case processing, literature cases, regulatory relavance determination, Admin edit and deletion of cases OCT-2014: Special Achievement award 1 for quality work from Quintiles Research India Pvt Ltd FEB-2015: Thank you letter for customer service from Quintiles Research India Pvt Ltd MAR-2015: Bravo for teamwork from Quintiles Research India Pvt Ltd JAN-2016: Thank you letter for customer service from Quintiles Research India Pvt Ltd FEB-2016: Two Bravo for teamwork from Quintiles Research India Pvt Ltd SEP-2016: Employee of the quarter from Quintiles Research India Pvt Ltd

Senior Pharmacovigilance Specialist 07/2017 - current
Clinipace Worldwide, Trivandrum, Kerala India
Working as a Senior Pharmacovigilance Specialist at Clinipace.Case management,safety management plan preparation, report generations. etc
• Prepare project specific Safety Management Plan, reporting forms, further applicable project specific instructions and participate in study start-up and site training when applicable. • Support other departments in safety issues, i.e. participate in the preparation of 'safety-sections' of bid defenses, trial protocols and clinical investigation plans. • Interact with the clinical team, medical monitors, investigative site personnel and sponsor representative for all initial and follow-up event information and query resolution. • Demonstrate an understanding of FDA and international regulations • Demonstrate the ability to apply clinical experience or pharmacovigilance experience in adverse event assessment. • Receive and enter initial and follow-up information for individual adverse event case reports, including creating narratives, into the Clinipace safety database, using data interpretation, coding and writing skills. Obtain approval of case report from Drug Safety Physician or Medical Monitor. • Identify and request appropriate follow up information on cases in consultation with the Medical Monitor and/or Drug Safety Physician, to ensure consistency of case entry and high data quality standards. • Produce regulatory report forms (e. g. Medwatch 3500 or CIOMS I) for regulatory submission within required timeframes to ensure regulatory compliance. • Produce and QC line listings to support safety surveillance activities. • Work with Data Management in the set-up and maintenance of the study specific safety database. • Cooperate with Data Management in conducting medical coding and reconciliation with the clinical database--
Senior Drug Safety Associate 03/2014 - 07/2017
Quintiles Research India Pvt Ltd, Bangalore, Karnataka India
Industry: Clincal Research Organization
Working as Sr. Drug Safety Associate in Quintiles Research India Pvt Ltd. Dealing with case management, AOSE writing, case unblinding, training etc
Initial receipt, database searches as necessary. Registry and triage of incoming cases to determine seriousness for prioritization of daily workflow. Preparation of AOSE/SUA/SUSAR summaries. Work allocation. Completion of case processing and quality review. Preparation of deviation memo as necessary. CAPA management and compliance monitoring. Case unblinding. Other case processing related activities including review of consistency checks, reconciliation, and daily pharmacovigilance agreement compliance tracking. Mentoring new hires. Conducting training in the team--
Drug Safety Associate 06/2013 - 03/2014
MMSH Clinical Research Pvt Ltd, Bangalore, Karnataka India
Industry: Clincal Research Organization
Worked as a Drug Safety Associate for 10 months in MMSH Clinical Research Pvt Ltd. Dealt with narrative writing for Clinical study reports.
Successfully handled safety writing for generating deliverables for 7 different US FDA approved clients. Drafted over 1000 + narratives till date which includes adverse events / serious adverse events / death cases / events of special interest(s) / withdrawal narratives / core SAE and more. Understand and adhere to narrative writing obligations by initiating and processing adverse event/serious adverse events/death/events of special interests narrative reports within approved timelines as defined in local and global work instructions, SOPs and regulations to meet local and global reporting requirements. Receive, prioritize and accurately transfers information from initial and follow-up source documents of adverse event/serious adverse events/death/events of special interests narrative reports to the appropriate fields. Assessment of case reports for seriousness, causality and expectedness. Keep track of the work progress and update the tracking tool. Participate in client meetings / project specific updates. Follow up with Clients regarding outstanding queries and reconciliation of discrepancies. Generation and management of query logs, resource tracker, deliverable tracker and comment logs.--
Drug Safety Associate 11/2012 - 03/2013
Synowledge PV Services India Pvt Ltd, Mysore, Karnataka India
Industry: Clincal Research Organization
Worked as drug safety associate for 05 months.
Successfully handled case processing for a US FDA approved client. End to End case processing of ICSRs including serious, non-serious and literature cases. Responsible for coding all medical history, events, drugs/procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD. Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in various fields. Responsible for coding all medical history, events, drugs/procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD). Responsible for writing medically relevant safety narrative of cases.--

National College of Pharmacy 08/2005 - 06/2010
Calicut, Kerala, India
Degree: Bachelor's Degree
Major:Pharmacy
Completed Bachelor degree in pharmaceutical science

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