GPV&E Resume

Global Pharmacovigilance & Epidemiology (GPV&E)

Highly experienced, dynamic, and effective professional with 17 years of experience in the pharmaceutical and medical fields. Expertly developed and implemented new procedures to facilitate regulatory success. Drafted summaries and analyzed clinical data for IND expedited safety reports and investigator brochures (IB). Substantially improved efficiency related to information retrieval and preparation of periodic safety update reports (PSURs) and PADERS.

Recognized for the ability to work collaboratively with cross-functional teams as part of a matrix system. Strong leadership capabilities with a demonstrated record of achievement in guiding process review teams regarding improving data quality of PSURs and other aggregate safety reports. Served as a strategic leader who promoted the exchange of ideas in an open forum to facilitate an organization of high performers. Professional strengths include:

* Project / Process Management
* Cross-Cultural Communications
* Cross-Functional Collaboration
* Document Analysis / Interpretation
* Team Leadership / Development
* Signal Detection / Regulatory Compliance
* Pharmacovigilance / Safety Systems
* Safety Document Development / Management

EXPERIENCE & ACHIEVEMENTS

ABC COMPANY, Smyrna, DE, 20xx – 20xx

Associate Director, Global Pharmacovigilance & Epidemiology (GPV&E), Medical Affairs (20xx-Present)

Guide the professional and personal development of a team of ten clinical scientists compiling antiviral and anti-infective aggregate safety documents, including PSURs, PADERs, expert ad-hoc reports, SUSARs, expedited reports, and ASRs for submission to global health authorities in accordance with SOPs and US and international regulations, including FDA and ICH guidelines.

* Led team meetings to review development of risk management and pharmacovigilance plans. Analyzed clinical data for IND expedited safety reports and IB updates. Collaborated with pharmaceutical research institute personnel to substantially improve efficiency of information retrieval.

* Drafted PSUR formats and SOPs for audit findings and aggregate listings. Ensured data were accurate and in compliance with standards established for regulatory submissions through effective and ongoing collaboration with product physicians, technical operations, the global regulatory team, adverse event (AE) processors, and other affiliates.

Manager Aggregate Reporting Group, GPV&E, Regulatory Affairs (20xx-20xx)

Directed and trained clinical scientists / associates regarding PSURs for all BMS marketed products, and prepared reports for regulatory submission. Ensured cross-functional teams worked together to streamline the collection of information in aggregate reporting. Contributed to the Coding Convention Committee.

* Selected as the contract project manager to handle recruitment, training, supervision, and support of external medical consultants compiling outsourced aggregate safety reports.

* Created an active Excel matrix to manage PSUR scheduling, which streamlined work flow and anticipated resource needs.

EDUCATION

UNIVERSITY OF XYZ – Bachelor of Science in Nursing (expected 20xx)
XYZ SCHOOL OF NURSING, Smyrna, DE

COMPUTER SKILLS

MedDRA (Hierarchy, SSCs, SMQs)
WHO-ART
Documentum System (CARA/PRISM) ART
MS Office Suite

We are glad to offer this free GPV&E resume resume sample free of charge. Review resume writing services, resume professionals, resume examples, resume objectives, resume tips, example resume formats, and helpful resume articles on this comprehensive site.

This free sample was provided by AspirationsResume.com
Review 1000+ free resume examples, compare resume writing services, find a local resume writer, and get free resume evaluations.

Advertisement