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Joy Cusker

309 Sandy’s Lane                                                                                            Cell Phone: 215.479.9876

 North Wales, PA 1901                                                             Email: joyccusker@drugsafetymatters.net                                                

EDUCATION:                                          Bachelor of Science in Pharmacy

                                                            Philadelphia College of Pharmacy, Philadelphia, PA

August 1991 – May 1996                                               

WORK EXPERIENCE:                

Jan. 2011 - Present                                Drug Safety Matters, LLC

Managing Partner                                              

                                                                       

·         Manage day to day operations for client projects including budget, resources, working instructions to achieve on-time, on- budget and high quality deliverable

·         Responsible for connecting with potential clients

·         Prepare proposals

·         Lead proposal defenses

Apr. 2010 - Jan. 2011                              Cephalon, Inc. via Synchrogenix,

Wilmington, DE           

                                                              Global Pharmacovigilance & Epidemiology          

                                                              Quality Control Specialist (Clinical & post-marketing)       

                                               

·         Conduct quality review of individual adverse event cases versus source documents     

·         Conduct quality review of all periodic and aggregate reports including PSURs and PADERs

·         Conduct quality review of ad-hoc reports, RMPs, RiskMAPs, update reports, ASRs, Labeling documents, unvalidated queries

·         Generate monthly Quality Review Summary reports

·         Support other compliance initiatives as needed

·         Identify trends and conduct root cause analysis based on quality review findings                  

Jan. 2009 – Mar. 2011                            Bridge Community Church     

Lansdale, Pa

Office/Operations Manager

·         Responsible for implementing church management software system

·         Preparation of operating procedures and guidelines

·         Liaison with third party vendors

·         Implement new and improved process and procedures to improve ministries

June 2008 – Jan. 2009                            Synchrogenix Medical Information Systems, Inc., Wilmington, DE

Senior Medical Writer

·         Prepared PSURs

·         Assisted in preparation of Post-Marketing Safety Discussion Documents

·         Assisted in preparation of ISS

·         Assisted in preparation of NDA

·         Preparation of Post-Marketing Pharmacovigilance/ Pharmacosurveillance SOPs

·         Performed clinical review of narratives for CSR inclusion

·         Act as client liaison for multiple projects

Oct. 2005 - May 2008                            Research Pharmaceutical Services, Inc.,

Fort Washington, PA

Project Manager, Drug Safety

Narrative Writing Projects (2 projects)

·         Utilized medical knowledge and writing skills to create comprehensive end of study adverse event report safety narratives for regulatory submission

·         Developed internal working instructions and processes

·         Trained medical writing team, quality control team and medical review team

·         Act as final QC of 2000 narratives to ensure consistency and accuracy

·         Liaison with sponsor company

·         Responsible for reporting metrics and managing progress of team

Legacy Data Entry Projects (2 projects manual entry)

·         Created mapping document, internal working instructions, training documents and processes for 2 safety databases. 

·         Responsible for development of metrics and managing progress of team to ensure manual entry of 1400 cases within the given timelines.

·         Liaison with sponsor company

·         Perform QC

                                                            Clinical Data Clean-Up

Team Lead Drug Safety Associate                                 

·         Coordinated the activities of a team of functional area key stakeholders (data management, safety, and clinical) to increase the efficiency of finalizing patients’ data in preparation of final database lock in a complex Congestive Heart Failure study of over 4,000 patients with a significant number of data endpoints and whose data are located in several distinct databases.

·         Communicated with functional area key stakeholders via a daily teleconference and on an ongoing ad hoc basis.

·         Identified challenges to database lock of patients that included SAE reconciliation issues, endpoint reconciliation issues, outstanding queries, and incomplete data and proactively resolved issues.

·         Addressed questions from monitors and site staff to ensure quick resolution to identified issues.

Other RPS responsibilities

·         Prepare presentations and participate in bid defense meetings

Apr. 2001 – Aug. 2004                           McNeil Consumer& Specialty Pharmaceuticals

                                                            Fort Washington, PA

                                                            Manager, Pharmacovigilance

·         Authored standard operating procedures and internal working practices in accordance with FDA regulations

·         Acted as Pharmacovigilance department liaison with Change/Information Management, third party vendors, internal and external call center, domestic and foreign affiliates

·         Increased productivity of data entry staff from five cases per hour to nine cases per hour.

·         Streamlined, validated, and trained staff on multiple adverse event entry, processing and reporting processes. 

·         Developed and executed plans for Adverse Event (AE) reporting system implementation, legacy data conversion, MedDRA implementation. 

·         Define metric system for department.

·         Hired and supervised data entry staff.

·         Defined functional requirements for AE reporting system.

Nov. 1996 – Dec. 2000                          McNeil Consumer HealthCare

Fort Washington, PA

Medical Affairs Specialist

·         Provided product information to healthcare professionals, sales representatives, and consumers via written and oral responses.

·         Brand Liaison to Marketing:  Maintained Q&As used by Consumer and Medical Affairs, assisted in development of educational materials for healthcare professionals, prepared and presented quarterly summaries of healthcare professional inquiries for assigned products.

·         Prepared expedited and periodic adverse event reports for submission to FDA.

·         Responsible for peer review of expedited safety reports to FDA. 

·         Prepared and presented quarterly summary of adverse drug events.

·         Acted as team leader for defining and analyzing current department workflow.

·         Evaluated third party call centers

PRESENTATIONS:                                 Multiple sales presentations and proposals

                                                            Preparing Safety Narratives at DIA Annual Meeting

                                                            Multiple Adverse Event Trainings

AFFILIATIONS:                                     Drug Information Association (DIA)

TRAINING:                                            DIA Medical Information Training, DIA Adverse Event Reporting,

Johnson and Johnson Leadership Trainings

MedDRA Training

COMPUTER SKILLS:                            MS Word, MS Excel, MS Power point, MS Outlook, Consumer response system, Lotus notes,   home-grown safety database used for product inquiry and product complaint tracking, Sceptre adverse event report system, DS Navigator, PV Works adverse event reporting system, Clintrace adverse event reporting system, Argus adverse event reporting system

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