Pharmacovigilance Manager at Vertex Pharmaceuticals
Greater Boston Area
Vertex Pharmaceuticals
Pharmacovigilance Manager
Greater Boston Area
Vertex Pharmaceuticals
Senior Pharmacovigilance Specialist
October 2015 to February 2018
Harvard Clinical Research Institute
Clinical (Safety) Specialist
July 2014 to October 2015
Harvard Clinical Research Institute
Clinical Safety Associate
December 2013 to July 2014
Harvard Clinical Research Institute
Clinical Safety Coordinator
December 2012 to December 2013
Greater Boston Area
PAREXEL
Clinical Research Assistant/Records Management Assistant
May 2012 to December 2012
Billerica,MA
Walgreens
Certified Pharmacy Technician
July 2007 to May 2012
Cambridge, MA
Massachusetts College of Pharmacy and Health Sciences
Undergraduate Research Associate
June 2009 to December 2009
Greater Boston Area
Saints Memorial Medical Center
Bioscience Academy Intern
January 2005 to June 2005
Lowell, Ma
đź“– Summary
Pharmacovigilance Manager @ Vertex Pharmaceuticals Greater Boston AreaSenior Pharmacovigilance Specialist @ Vertex Pharmaceuticals From October 2015 to February 2018 (2 years 5 months) Clinical (Safety) Specialist @ Harvard Clinical Research Institute From July 2014 to October 2015 (1 year 4 months) Clinical Safety Associate @ Harvard Clinical Research Institute From December 2013 to July 2014 (8 months) Clinical Safety Coordinator @ Harvard Clinical Research Institute • Provide administration support to the manager of Clinical Safety as well as other department personnel.• Work under general supervision to complete first line case evaluation/triage, initial data entry guidelines for Safety database,and coordinate case completion by Safety Associates.• Compile and distribute source document packets to Safety Associates for safety case completion.• Maintain and update tracker for intake of serious adverse event reports and distribution of reports to multiple external recipients.• Assist in devising and implementing standard Safety Trial Binders.• Organize and distribute internal and external safety reports electronically.• Assist Safety Associates with the creation of trial specific Safety Folders, updating and maintaining follow up information as necessary. From December 2012 to December 2013 (1 year 1 month) Greater Boston AreaClinical Research Assistant/Records Management Assistant @ PAREXEL •Creation, maintenance, and archive of Trial Master Files in accordance with PAREXEL Standard Operating Procedure (SOP), GCP, and FDA regulations. •Maintain PAREXEL’s electronic document management system, and ensure quality and content of paper and electronic central files. •Create paper/electronic folders for central file and associate electronic/paper information to electronic/paper folder as appropriate.•Ensure that all components of a specific document are present and follow up with respective team member if necessary.•Identify duplicates and unnecessary documents to ensure quality of central files •Coordinate close out activities of central files and provide support to Clinical team for termination visits to ensure proper documentation according to sponsor needs.•Communicate with project team to resolve discrepancies and suggest solutions.•Review relevant changes in CFMP in accordance to current SOP and assist team members to transition over efficiently•Name, upload, and perform scan image checks of electronic documents. •Track, scan, code, file, and retrieve documents as requested for project team members. •Support project team for internal and external audits.•Provide administration support, including the set-up of meetings, record meeting minutes, preparing memos, faxing, copying and scanning. •Ensure up to date study documents in tracking systems / document repositories •Liaise with Clinical Operation Lead and Project Lead•Prioritize completion of tasks according to projects’ needs and deadlines•Accurately estimate time needed to complete tasks within project timelines•Provide input to relevant project guidelines as required•Provide project specific training to other RMA or project team members•Identify inconsistencies and inefficiencies in processes and recommend solutions•Recognize out of scope activities and communicate to responsible Project or Functional Leader From May 2012 to December 2012 (8 months) Billerica,MACertified Pharmacy Technician @ Walgreens •New patients’ information data entry; transferred prescriptions; third party billing•Entered, filled, and dispensed prescriptions •Processed and filed all paperwork such as daily deletes, transfers, smart counts, and warehouse inventories•Assisted in compounding prescriptions •Assisted patients with prescription, third party, or general store inquiries •Collaborated with doctors and insurance companies on prescription inquiries From July 2007 to May 2012 (4 years 11 months) Cambridge, MAUndergraduate Research Associate @ Massachusetts College of Pharmacy and Health Sciences •Assisted in three different Graduate research projects on Masters and PhD levels-Project 1: cultured PC12 cells for an in vitro toxicity and efficacy evaluation of new Coumarin derivatives-Project 2: worked with rats for a study on the behavioral effects of metal contaminated water and ADHD -Project 3: cultured neuroblastoma cells on the effects of the Peruvian plant, Lepidium meyenii, as a cannabinoid in vivo From June 2009 to December 2009 (7 months) Greater Boston AreaBioscience Academy Intern @ Saints Memorial Medical Center •Shadowed healthcare professionals •Dealt with patient care•Assisted nurses with dialysis•Assisted pharmacy technicians in dispensing medications From January 2005 to June 2005 (6 months) Lowell, Ma
What company does Bunnary Am work for?
Bunnary Am works for Vertex Pharmaceuticals
What is Bunnary Am's role at Vertex Pharmaceuticals?
Bunnary Am is Pharmacovigilance Manager
What industry does Bunnary Am work in?
Bunnary Am works in the Biotechnology industry.
Who are Bunnary Am's colleagues?
Bunnary Am's colleagues are Sandy Yates, Alma Selles, Patricia Apruzzese, Rick Palma, and Jayashree Kumar
Extraversion (E), Sensing (S), Feeling (F), Judging (J)
1 year(s), 6 month(s)
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