Denise Klug Rn, Clnc
About Denise Klug Rn, Clnc
Denise Klug is a Senior Drug Safety Specialist at Alkermes with over 27 years of experience in healthcare, including more than 16 years in the drug safety industry.
Company
Denise Klug is currently employed at Alkermes in Waltham, Massachusetts, where she serves as a Senior Drug Safety Specialist, a role she has held through August 2023. Alkermes is a biopharmaceutical company dedicated to developing innovative medicines for the treatment of central nervous system (CNS) diseases.
Previous Positions
Prior to her current role at Alkermes, Denise Klug served as a Drug Safety Specialist II from 2016 to 2019. Before Alkermes, she worked at Quintiles in various capacities, including Operations Specialist Associate Manager for 3 months in 2016, Senior Operations Specialist from 2013 to 2016, and Operations Specialist from 2011 to 2013. Additionally, Denise served as a Pharmacovigilance Coordinator I at i3 Drug Safety/Ingenix from 2007 to 2010 and as a Registered Nurse at Oakwood Southshore Hospital for 10 years from 1997 to 2007.
Education and Certifications
Denise Klug studied Certified Legal Nurse Consultant (CLNC) at the Vickie Milazzo Institute, attaining her certification from 2014 to 2015. She also earned an Associate of General Science degree and an Associate of Applied Science in Nursing (RN) from Wayne County Community College District, where she studied Biology/Biological Sciences and Registered Nursing, respectively.
Experience in Drug Safety
Denise Klug has more than 16 years of experience in the drug safety industry. She specializes in performing aggregate report clean-up and conducting precise SAE (Serious Adverse Event) reconciliations. Her responsibilities also include managing data migration, updating process documents, and revising SOPs. Denise has managed Investigator Sponsored Studies, served as a point of contact, and provided training for external vendors. She also took part in compiling and supplying safety information for regulatory submissions including IND safety reports and clinical study reports.
Professional Skills and Responsibilities
At Alkermes, Denise Klug authored and revised SOPs, Work Instructions, and Data Handling Conventions. She conducted precise coding of verbatim adverse events, medical history, and medications, and authored comprehensive narratives to verify the accuracy of safety data. Denise assisted program managers with filling out data configuration forms and tested them in ARGUS. Additionally, she participated in various meetings to ensure the accuracy of safety information and collaborated with management to develop operating procedures and processes for pharmacovigilance.