Summary
Overview
Work History
Education
Skills
Certification
Affiliations
Timeline
Generic

Maria Krenick

Monroe Twp,NJ

Summary

Strategic-thinking individual with 20 years of Drug Safety, Risk Management, Signal Detection and leadership skills.

Over 15 years of mentoring and training experience through-out different departments. Continuously demonstrated to increase efficiency and improve quality by identifying improvements in department process.


Overview

33
33
years of professional experience
1
1
Certification

Work History

Director of Pharmacovigilance & Medical Affairs

Optinose US, Inc
Yardley, Pennsylvania
02.2018 - Current
  • Managed daily operations while overseeing a call center responsible for customer calls, medical information and product quality complaints as well as a PV vendor that managed case processing, signal detection and aggregate reports
  • Review and approve all business process, SMP, and client directives.
  • Developed impactful and strategic partnerships with clients to drive business development.
  • Created annual budget and developed comprehensive plan to accomplish company objectives while staying within budget.
  • Trained outside vendors on Adverse Event reporting
  • Contribute and approve PADER's, Annual Reports and DSURs, while overseeing collaboration of all departments are submitted to outside vendor in a timely fashion.
  • Worked closely with Marketing, Sales and Market Access to ensure PV requirements are met.
  • Directly oversee risk management and signal detection dissemination to internal stake holders.
  • Responsible for review of all protocols and creation of SMP in collaboration with CRO and PV vendor.
  • Responsible for all SDEA's with external parties.
  • Ensure timely submissions of all ICSR's, PADER's DSURs to Authorities and other parties.
  • Saved 20% by implementing cost-saving initiatives that addressed long-standing problems
  • Supported the RFP process and part of final selection process between vendors.

Director of Product Safety and Medical Affairs

MEDA Pharmaceuticals
Somerset, NJ
01.2006 - 09.2017
  • Reported to QPPV, served as "Local Safety Officer" for US.
  • Responsible for identification of any emerging safety issue and communication across all functional teams.
  • Managed internal team as well as outside Vendor for Call Center and PV activities, case processing and submissions.
  • Part of Marketing Program Review committee to ensure compliance Marketing programs and Speaker programs and compliance with PV requirements
  • Responsible for timely submission of all ICSR, PADER's, and aggregate reports to authorities.
  • Worked with clinical team and CRO's on writing and approving all SMPS.
  • Reviewed and provided feedback on clinical trial protocols.
  • Writing and review of SDEA's, SOPS,s as necessary for business needs.
  • Experience in OTC, Nutritional Supplements, Clinical and Post-Marketing spontaneous report processing.
  • Point person for Regulatory Authority audits.

Safety Surveillance Associate

Pfizer Pharmaceuticals
New York City/ Bridgewater, NY, NJ
03.2004 - 01.2006
  • Communicated with internal and external contacts to resolve issues related to case processing.
  • Prioritized case processing deliverables to accomplished work in established timeframes.
  • Compared adverse event source documents against safety database screens for transcription and medical accuracy.
  • 100 % compliance in ICSR submissions , PADERs and DSUR consecutively for 3 years

Consultant Safety Specialist at Pfizer

Pro-unlimited
New York City, New York
09.2002 - 03.2004
  • Collaborated with safety writing team on PADERs and PSURs to ensure complete and timely submissions to Regulatory reports group.
  • Processed cases, spontaneous, solicited, literature and legal cases, ensured coding, labeling assessment and narrative accuracy.
  • Ensured completion of case work load and data clean-up for aggregate reports.

Clinical Research Consultant

Advanced Biomedical Research Co
Hackensack, NJ
09.2001 - 09.2002
  • Performed Randomization and dispensing of study drug to in-patients.
  • Performed inventory of study drug and documentation for two trials.

Pharmacy Owner/Pharmacist-in-Charge

Newport Pharmacy
Jersey City, NJ
07.1987 - 09.2000
  • Managed/supported daily operations of high volume prescription department, managing drug supply and inventories
  • Supervised staff pharmacist and employees while delegating responsibilities.
  • Served as Liaison between Physician/patient and managed care facilities to acquire prior authorizations.
  • Provided patient counseling and advice on prescriptions as well as alternatives

Education

Bachelor of Science - Pharmacy

St Johns College of Pharmacy
Queens, NY
05.2005

Skills

    • Excellent time management, multi-tasking and prioritizing
    • Effective leadership and team collaboration
    • Proficient in ArisG/ Lifesphere and Argus
    • Strong Knowledge of ICH, FDA, EMEA guidelines and Regulations
      • Experience in MedDRA and Who Drug Coding
      • Point person for Regulatory Audits (participation in MHRA, BPharm and FDA) audits
      • Fluent in English and Spanish

Certification

  • Pharmacovigilance Certification - Rutgers University 2013-2014


Affiliations

  • Member of RAPS (Regulatory Affairs Professionals Society)

Timeline

Director of Pharmacovigilance & Medical Affairs

Optinose US, Inc
02.2018 - Current

Director of Product Safety and Medical Affairs

MEDA Pharmaceuticals
01.2006 - 09.2017

Safety Surveillance Associate

Pfizer Pharmaceuticals
03.2004 - 01.2006

Consultant Safety Specialist at Pfizer

Pro-unlimited
09.2002 - 03.2004

Clinical Research Consultant

Advanced Biomedical Research Co
09.2001 - 09.2002

Pharmacy Owner/Pharmacist-in-Charge

Newport Pharmacy
07.1987 - 09.2000

Bachelor of Science - Pharmacy

St Johns College of Pharmacy

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Maria Krenick