Assertio Therapeutics, Inc.

Director, Drug Safety & Risk Management

Location
Lake Forest, IL, US
Posted
Jul 16, 2019
Ref
2019-1037
Hotbed
BioMidwest
Required Education
Doctorate/PHD/MD
Position Type
Full time

Responsible for executing and managing pharmacovigilance activities that include adverse event reporting, safety assessments, signal detection and aggregate reporting in compliance with applicable FDA and global regulations and Assertio standard operating procedures and guidelines. Responsible for internal processes that include the ongoing maintenance of adverse event workflow, department policies and standard operating procedures, and manage the department relationship with business partners. Externally work with business partners to ensure execution of contracts that include, but are not limited to safety vendor/s, companies with whom we have PV agreements to meet global regulatory reporting requirements and support other Assertio business areas. Assist with the preparation of internal and external reports (e.g. PADERs) and production and distribution of routine pharmacovigilance metrics. Help drive internally, and collaborate with external partners, in the development and execution of risk management activities including Risk Evaluation and Mitigation Strategies (REMS) programs. on projects and activities to support Assertio's REMS programs. Responsible for executing and managing pharmacovigilance activities that include adverse event reporting, safety assessments, signal detection and aggregate reporting in compliance with applicable FDA and global regulations and Assertio standard operating procedures and guidelines. Responsible for internal processes that include the ongoing maintenance of adverse event workflow, department policies and standard operating procedures, and manage the department relationship with business partners. Externally work with business partners to ensure execution of contracts that include, but are not limited to safety vendor/s, companies with whom we have PV agreements to meet global regulatory reporting requirements and support other Assertio business areas. Assist with the preparation of internal and external reports (e.g. PADERs) and production and distribution of routine pharmacovigilance metrics. Help drive internally, and collaborate with external partners, in the development and execution of risk management activities including Risk Evaluation and Mitigation Strategies (REMS) programs. on projects and activities to support Assertio's REMS programs.

Responsibilities

Essential Job Function
 

  • Review adverse event information received by Pharmacovigilance vendors for clinical accuracy, completeness and consistency
  • Report within timelines CIOMS
  • Review submissions to FDA made on behalf of Assertio for clinical accuracy, completeness and consistency
  • Reviews case information for appropriate distribution to internal and external business partners
  • Assists in the compilation of individual and aggregate reports (PADERs, etc.) per U.S. regulations
  • Act as primary point of contact for safety reporting in ongoing trials
  • Participate on relevant safety monitoring boards, if requested
  • Work with Clinical Ops to draft and finalize Safety Management Plans
  • Act as a liaison with internal departments and external business partners on Drug Safety and Pharmacovigilance operation management issues and clinical study related activities
  • Provide safety monitoring and PV expertise to synopsis and protocol development
  • Guide and provide expertise to the vendors in signal detection activities
  • Ensure compliance with corporate and departmental standard operating procedures
  • Support Clinical Development in the development and maintenance of relevant safety SOPs
  • Lead corporate training initiatives on safety reporting
  • As an individual contributor, may serve as a project manager for functional projects or workflows
  • Contribute data to product labelling efforts where appropriate

 


Additional Responsibilities/Duties

 

 

  • Minimum 2+ years of experience in drug development, synopsis, protocol, CSRs and IB development and data review

 


Qualifications

Education and Experience

 

 

 

  • MD degree and 5-7 years of experience, or equivalent combination of education and experience
  • 5+ years in Pharmacovigilance & Risk Management, and combination with Clinical Development
  • Must be authorized to work in the U.S. on a permanent basis without sponsorship in the future
  • Experience in phases I-IV drug safety surveillance
  • Knowledge of FDA and international adverse event reporting regulations per ICH guidelines and the ability to interpret and apply applicable regulations to resolve issues
  • Preferably knowledge of Pain Therapy and CNS disease states
  • Advanced working knowledge of clinical and post-marketing database systems
  • Proficient in MedDRA coding of medical terminology and WHO-DD drug classification
  • Demonstrated competence in obtaining, analyzing, disseminating, and reporting safety information in compliance with global regulations
  • Experience with preparation of investigational and post-marketing regulatory reports

 


Skills and Abilities

 

 

 

  • Excellent oral and written communication skills
  • Proven ability to critically evaluate and summarize clinical and scientific data
  • Highly organized and demonstrates consistent attention to detail
  • Must demonstrate accountability for delivery of results and have good problem-solving and decision-making skills
  • Must be able to manage their own work, with ability to prioritize, plan and organize work assignments while working under strict timelines
  • Must have the ability to follow established processes and the flexibility to adopt new practices and priorities as required
  • Must have the ability to operate in fast-paced, timeline-oriented, team environments/matrix organizations
  • Proficiency in standard desktop software programs (Word, Excel, Outlook)

 


Assertio Competencies Include

 

 

 

  • Integrity
  • Decisions & Judgment
  • Ownership & Initiative
  • Adaptability & Change Readiness
  • Teamwork & Collaboration

 


Physical/Mental Demands

 

 

 

 

  • Travel: Ability to travel for meetings and events

 


Accommodations for Applicants with Disabilities

Assertio is proud to create a culture of inclusion and diversity and be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

We provide reasonable accommodations to qualified applicants with disabilities and to disabled veterans in accordance with the ADA. If you require a reasonable accommodation for any part of the application process due to a medical condition or disability, please email hr@assertiotx.com or call 224-441-6867 for assistance.

For more information about your EEO rights as an applicant under the law, please click here.