Pharmacovigilance Case Manager — Adverse Event Specialist

Mindlance, Inc.; Indianapolis (IN); On-site; USD 50,000 - 65,000; Full time

Job summary

A healthcare consulting firm is seeking a Case Management Associate in Indianapolis, IN, to manage adverse event reporting and ensure compliance with regulatory standards. Candidates should hold a Bachelor's degree in a healthcare-related field and possess strong communication skills. Key responsibilities include reviewing safety reports and collaborating with various stakeholders. This role demands strong organizational skills and the ability to adapt to changes in a fast-paced environment.

Qualifications

• Bachelor's degree or higher in a healthcare-related field or life sciences required.
• Fluent written and verbal communication skills in English.
• Demonstrated competency in IT platforms and databases.

Responsibilities

• Manage entry and review of adverse event reports in safety database.
• Develop expertise in pharmacovigilance regulations.
• Communicate effectively with internal and external stakeholders.
• Collaborate with affiliates and response teams.

Skills

Effective communication skills

Organizational skills

Ability to manage multiple tasks

Problem-solving skills

Interpersonal skills

Fluent in English

Understanding of global regulations

Education

Bachelor's degree in healthcare or life sciences

Tools

Microsoft Office

Job description

Mindlance is a national recruiting company which partners
with many of the leading employers in the Life Sciences, IT, and Financial
Services sectors, feel free to check us out at http://www.mindlance.com.

Job Description

Job Title: Case Management
Associate

Job Duration: 18 months +

Job Location: Indianapolis, IN,
United States

JOB
DETAILS:

Manage adverse event reporting. Stay current regarding FDA and global
regulations with respect to safety reporting and pharmacovigilance. Ensure
regulatory compliance for expedited submission of case reports. Maintain an
understanding of current labeling practices (e. g. , USPI, Core, CIP and
EUSPC). Interact with internal and external customers. Provide support
regarding Global Product Safety (GPS) policies, processes and procedures.
Support product safety surveillance activities.



Education:

• Bachelor's degree(or higher) in a healthcare-related
  field or life sciences field or demonstrated equivalent experience is
  required
• Demonstrates basic clinical knowledge of various
  disease states
• Effective communication skills (verbal and written)
• Demonstrates competency in IT platforms including
  databases, Microsoft Office, and CLIENT web based collaboration sites
• Ability to manage multiple concurrent tasks; good
  organizational skills, attention to detail; ability to focus for long
  periods of time on detailed information; consistently prioritizes work and
  makes decisions that comply with applicable timelines
• Effectively analyzes possible solutions to solve a
  range of problems
• Effectively responds to customer requirements and
  requests
• English language skills — fluent written and verbal
  communications
• Knowledge of global regulations with respect to adverse
  event reporting
• Knowledge and understanding of GPS policies and
  procedures
• Ability to learn quickly and adapt to a changing
  environment
• Flexibility to adapt to changing priorities
• Demonstrated interpersonal skills; ability to work as
  part of a team
• Ability to see the big picture; use logic to solve
  problems

Primary Position Responsibilities (major or daily tasks)



Purpose: The purpose of the Associate/Senior Associate/Associate Consultant
Case Management (Case Manager) role is to be responsible for adverse event
report handling. This includes assessing and processing individual adverse
event reports; maintaining awareness of global pharmacovigilance regulations;
ensuring regulatory compliance for expedited submission of individual case
reports; collaborating with internal and external business partners as well as
other duties as assigned. An associate's responsibilities can vary depending on
the needs and focus of a particular team as well as the global case manager
competency model.



Responsibilities:



Adverse Event Case Management:

• Responsible for review, entry, assessment, and
  acknowledgement of adverse event reports in the safety database
• Develop an understanding/expertise of pharmacovigilance
  regulations
• Comply with internal and external timelines for
  managing adverse event data entry and expedited reporting processes as
  appropriate
• Creation of a case narrative
• Attempt to obtain follow-up information from external
  parties through effective written and oral communications
• Perform typical case management assessment activities
  which include (but not limited to): o Select individual adverse event
  terms o Code events to appropriate MedDRA terms o Manage and assess
  appropriate serious outcome criteria for adverse events o Assess listed
  ness - evaluate the case against the appropriate product information o
  Determination of whether medical physician safety review is necessary. o
  Determine what, if any, follow-up information is needed Global Support:
• Keep current on global regulatory issues and practices
  related to GPS
• Understand and apply GPS business practices
  Collaboration/Support Internal and External Customers
• Communicate effectively with CLIENT Corporate contacts
  from affiliate offices, call center contacts, legal, customer response
  teams, and other customer groups
• Understand the confidential nature of company
  information and take necessary steps to ensure its protection

Qualifications

bachelors , RN( registered nurse)

Additional Information

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