Associate, Drug Safety

Job Summary

The Associate, Drug Safety is responsible for day-to-day case management of adverse event records for Proactiv. This position will assess incoming communication to identify potential adverse event reports and provide medical evaluation of adverse events reports. This role is responsible for handling adverse event accountabilities in order to comply with local and international regulations, guidelines and applicable directives.

Responsibilities

• Evaluates incoming communication for potential adverse event reports via local intake system, phone, fax, mail, social media and other methods in the Wilke database.
• Medically evaluates and processes adverse event reports daily from the Wilke database for possibility of seriousness and expedited reporting to FDA and Health Canada. Reports cases to the proper regulatory authority within the required reporting period, as needed.
• Processes daily queries and provides response within the same business day.
• Processes literature cases as needed and maintains literature report spreadsheet.
• Provides AE Case follow up and maintains report spreadsheet.
• Ensures receipt of adverse events from Marketing programs.
• Supports internal audits and external inspections.
• Performs trending for adverse event reporting by preparing quarterly reports.
• Prepares Annual Summary report for drug products marketed in Canada.
• Performs reconciliations for Product Quality complaints and reports involving partners.
• Conducts monthly Health Canada Adverse event search in the Vigilance database.
• Maintains a working knowledge of:
• Company policies and procedures, departmental processes and associated work instructions.
• Evolving local and international regulations, guidelines and applicable directives.
• Alchemee products
• Maintains knowledge of skin anatomy and skin diseases
• Updates SOP’s and work instructions as needed.
• Other duties as assigned
  

The presently-anticipated base compensation pay range for this position is $94,500 to $105,000. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.