Medical Customer Service

LAXMA 408-***-****, ************@*****.***

OBJECTIVE

Seeking a challenging position of Drug Safety Associate to promote growth, stability and opportunity for advancement

SUMMARY

More than four years of experience in pharmacovigilance within the pharmaceutical industry

Sound understanding of IND safety reports, 21 CFR part 11, GCP, GLP, ICH and HIPPA guidelines

Competence in the processing and assessment of safety reports, regulations and reporting requirements, including both prescription and over the counter products

Extensive working knowledge of FDA regulations, FDA guidelines, and ICH guidance; some exposure to EMEA regulations

Exceptional ability to communicate on professional level with physicians, nurses, pharmacists, and other professional staff when discussing products

Clinical trial safety experience (SAE/AE, writing narratives, case processing, and reporting)

Experience with preparation of investigational and post marketing regulatory reports

In-depth knowledge of the language of regulatory bodies, coding principles, submission criteria, regulatory timeline requirements, technical requirements and guidelines

Proficient in data entry into drug safety database

Concrete knowledge of drug development process including clinical research activities and reviewing of medical records

Analytical, accurate and detail-oriented in ensuring the success of the project as per the guidelines

Advanced customer service skills to meet or exceed customer expectations

Strong verbal and written communication skills and a demonstrated ability to work cross-functionally

Remarkable project management skills, ability to manage multiple high priorities, identify resource needs, drive to completion, prepare reports, and evaluate results

Good leadership skills including training, influencing and motivating staff members to achieve company safety objectives

Ability to set own priorities and function independently or as a member of a team

PROFESSIONAL EXPERIENCE

Noven Pharmaceuticals, Inc., New York, NY

Drug Safety Associate May 2011 – March 2012

Provided ongoing safety surveillance and signal detection/analysis in individual studies, and across studies using the same compound

Support for active signal detection processes and support the Safety Review Board and Risk Management Teams; ad hoc review of any safety issues as needed

Worked closely with Pharmacovigilance Data Managers and Quality Managers and provided back-up in their absence for triage of incoming cases and QC of case entry

Collected details of adverse events received by phone or mail for drugs and biologics and performed initial assessment according to local procedures and in accordance with company global drug safety procedures

Uploaded, filed, and approved response documents into the medical information database; compiled and analyzed medical information reports

Responsible for monitoring the company’s clinical trial drug surveillance program including the intake, evaluation, processing and follow up of serious adverse event reports

Created initial reports by directly entering information into Drug Safety databases, amended reports and entered follow-up information as acquired, and prepared reports for FDA submission

Regularly communicated with the client regarding the updated guidelines for processing the cases towards each product

Participated in clinical trial individual patient data review of adverse events, protocol compliance, efficacy and safety assessments along with the Medical Project Team of Medical Monitors, Medical Project Managers, and Clinical Research Associates

Acorda Therapeutics, Inc., Hawthorne, NY

Drug Safety Scientist Feb 2009 - Apr 2011

Reviewed patient medical records and reported the adverse events to the drug safety professionals

Prepared a clinical narrative (CIOMS/3500A) and independently assigned MedDRA terms and labeling to adverse events while maintaining compliance timelines

Coordinated submission of technical complaints to the Quality Assurance dept and the matching of technical complaints that also involved adverse events

Documented medical inquiries regarding product complaints and adverse events and created positive customer interactions

Participated in the set-up and maintenance of adverse event workflow processes, department policies, and standard operating procedures

Acted as a liaison with internal departments and external business partners on operation management issues and clinical study related activities

Utilized internet/electronic databases to search for published literature on Acorda products

Provided written summaries for internal distribution and medical information response

Performed daily triage of information contained in the safety mailbox, inclusive for all products

Performed remediation for non-compliance with Adverse Event/ Product Complaint reporting Standard Operating Procedure

Received and responded to telephoned medical inquiries from healthcare professionals regarding all marketed products and products being prepared for launch

Performed accurate computer data entry of identified AE and other case information; and ensured uniform and timely processing of adverse event data

Ensured entry and follow-up of products complaints, linked AEs with product complaints and obtained analysis results from the complaint database

Solvay Pharma India Limited, Mumbai, India

Associate Drug Safety Monitor July 2008 - Dec 2009

Performed data entry for tracking and safety database, coding relevant medical terminology, writing descript narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations and ensuring reports are sent to the customer within assigned deadlines

Processed Lifecycle Safety data according to applicable regulations, guidelines, Standard Operating procedures and project requirements

Contributed under guidance of senior staff to individual deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information

Observed post-marketing safety surveillance including signal detection

Provided data management, report preparation and appropriate dissemination of spontaneous non- serious and serious adverse event information for legacy consumer healthcare products

Sunshine Life Science, Gujarat, India

Clinical Research Coordinator Dec 2007- June 2008

Planned, implemented and monitored participant recruitment and retention procedures, used media outlets, questionnaires and interviews to recruit and screen research participants

Oversaw staff recruitment and education regarding the design, length and other details of the research study

Interpreted and implemented protocol procedures and policy

Maintained case report forms, charts and documentation

Dispensed medication and reviewed lab and procedure results

Scrutinized and reported adverse events in timely fashion

EDUCATION & CREDENTIALS

Bachelor of Pharmacy

Sarojini Ramulamma College of Pharmacy, Osmania University, Hyderabad, India

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