Summary
Overview
Work History
Education
Skills
Certification
Therapeutic Experience
Languages
Timeline
Generic

David Mack

Cincinnati

Summary

Knowledgeable Drug Safety Specialist and Project Lead with solid foundation in specialized tasks and track record of delivering results through targeted initiatives. Proven ability to implement effective strategies that enhance operational efficiency and support team objectives. Demonstrated proficiency in problem-solving and project management.

Overview

25
25
years of professional experience
1
1
Certification

Work History

Safety & PV Project Delivery Lead, Sr Safety and PV Specialist

Syneos Health
07.2020 - Current
  • Performs all aspects of the collection, processing, and reporting of individual cases safety reports (ICSR), adhering to all data privacy guidelines, Good Clinical Practices (GCPs), Good Pharmacovigilance Practice (GVP), regulatory guidelines, company and project/program-specific procedures for clinical trials and/or post-marketing safety programs; Ensures that the project/program activities are completed in accordance with agreed timelines, allocated budgets and required quality standards; Responsible for providing delivery and expertise with minimal oversight; Coordinates workflow to ensure delivery of project/program; Accountable to the Project Lead or Safety Program Delivery Manager at the project/program level and line manager for deliverables; May act as a mentor for less experienced associates; At a project level, may act as Safety Program Delivery Lead for local or regional studies.

Senior Safety Specialist

Syneos Health (Previously INC Research)
10.2016 - 05.2019
  • Performs all aspects of the collection, processing, and reporting of adverse events adhering to all data protection guidelines, Health Insurance Portability and Accountability Act (HIPAA), Good Clinical Practices (GCPs), regulatory guidelines, and study procedures. May lead or oversee one or several projects of various levels of complexity; Manages daily workload of Safety Specialists within the department with limited line management responsibilities; Mentors and trains junior Safety Specialists. Ensures that the project activities are completed in a timely manner with acceptable quality and acts as a decision maker; Supports business development activities and delivers presentations; Interfaces between Company, sponsors, vendors, and other departments in the area of safety and pharmacovigilance; assists in the design and implementation of safety collection, processing, and reporting systems; acts as a primary point of contact for information regarding projects; Represents Safety and Pharmacovigilance on cross functional teams.

Safety Specialist II

INC Research LLC (Kendle International, Inc.)
05.2011 - 10.2016
  • Performed day to day processing of adverse events for assigned projects under the direction of more senior safety personnel; provided oversight and project guidance to junior safety personnel; oversees all aspects of safety reporting for assigned projects.

Safety Specialist I

Kendle International Inc.
03.2004 - 04.2011
  • Assisted in the day-to-day processing of adverse events for assigned projects under the direction of more senior safety personnel; Position involved the use of Kendle's or Sponsor's computerized adverse event database; Utilized appropriate skills and experience, may also be selected to act as the Safety Project Leader (SFPL) for one (1) or more studies. Specific responsibilities included both project performance and financial accountability.

Registered Nurse

The Christ Hospital, PACU
12.2001 - 03.2004
  • Provided all aspects of immediate post-op surgical care for patients having both simple and complex surgical procedures; Responsibilities included: Airway management, pain control, recovery from anesthesia and immediate post-op orders implementation; Acted as an ICU overflow area for critical surgical patients when the SICU unit was at its maximum census; Acted as evening/night charge nurse and was responsible for all aspects of the unit including staffing issues and proper patient placement in other units; Responsible for communicating with all surgical units on a nightly basis to coordinate the placement of patients for the next surgical day; Took night and weekend call in order to provide continuous staffing for emergency cases.

Registered Nurse

The Christ Hospital, MICU
09.2000 - 12.2001
  • Provided all aspects of nursing care for patients having complex medical problems requiring intense and closely monitored care; Responsible for monitoring and interpretation of complex patient equipment including Swan Ganz catheters, arterial lines, balloon pumps and continuous EKG machines; Responsible for responding to a code blue within the hospital when designated; Acted as night charge nurse and was responsible for all aspects of the unit including staffing issues and coordination of placement of patients in the MICU; Took night and weekend call in order to provide adequate staffing for patient care.

Education

Diploma - Nursing

Christ Hospital School of Nursing
01.2000

Bachelor - Business Administration

Miami University
01.1995

Skills

  • Customer relations
  • Expert problem solving
  • Analytical thinking
  • Documentation management
  • Advanced communication
  • Proficient in Microsoft Outlook, Word and Excel
  • Coaching and mentoring
  • Multitasking
  • Organizational skills
  • Excellent communication

Certification

  • Registered Nurse
  • September 2000

Therapeutic Experience

  • Analgesia - Fibromyalgia
  • - Pain
  • - Pain, Back
  • Analgesia - Analgesia/Anesthesiology - Neck Pain
  • CNS Psychiatry - Bipolar Disorder
  • - CNS Psychiatry - Opioid Addiction
  • - Schizophrenia
  • Cardiovascular - Hypertension
  • - Thrombosis, Deep Vein
  • Endocrinology - Endocrinology - Type 1 Diabetes Mellitus
  • Gastroenterology - Nausea
  • Hematology - Anemia
  • Infectious Disease - Infection, Common Cold
  • Neurology - Epilepsy
  • - Multiple Sclerosis
  • - Parkinson's Disease
  • - Restless Legs Syndrome
  • - Seizure Disorders
  • Oncology - Cancer, Colorectal
  • Psychiatry - Addiction, Alcohol
  • - Attention Deficit Hyperactivity Disorder
  • Respiratory - Allergy
  • Skeletal Diseases - Rheumatoid Arthritis

Languages

English
Native or Bilingual

Timeline

Safety & PV Project Delivery Lead, Sr Safety and PV Specialist

Syneos Health
07.2020 - Current

Senior Safety Specialist

Syneos Health (Previously INC Research)
10.2016 - 05.2019

Safety Specialist II

INC Research LLC (Kendle International, Inc.)
05.2011 - 10.2016

Safety Specialist I

Kendle International Inc.
03.2004 - 04.2011

Registered Nurse

The Christ Hospital, PACU
12.2001 - 03.2004

Registered Nurse

The Christ Hospital, MICU
09.2000 - 12.2001

Bachelor - Business Administration

Miami University

Diploma - Nursing

Christ Hospital School of Nursing

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