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Pharmacovigilance Operations Manager I

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About the role

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Mapi is adding a Pharmacovigilance Operations Manager to our North American team!    


Responsibilities/Accountabilities:

The Pharmacovigilance Operations Manager  is responsible for management of Individual Case Safety Reports (ICSRs) in compliance with applicable regulation, the company's Standard Operating Procedures, and project-specific operational agreements. 

The primary responsibilities include:
  • Prioritizing and complete multiple projects within established time frames.
  • Managing client projects, including managing client relationships and project budgets.
  • Entering source information for ICSRs into safety databases and/or tracking systems ensuring accurate data-entry.
  • Preliminary triaging of ICSRs to determine classification, priorities and time frames for subsequent activities.
  • Performing preliminary coding of ICSRs using MedDRA, WHODrug and database-specific dictionaries.
  • Completion project-specific report forms with available information for ICSRs.
  • Preparing draft narratives for ICSRs.
  • Medical review of ICSRs, only if medically qualified (physician, pharmacist, nurse).
  • Performing quality control review of ICSRs to ensure accuracy and completeness of data-entry.
  • Contacting reporters of ICSRs to collect additionall information, supporting documents and answers to queries within pre-defined parameters.
  • Determine if ICSRs require submission to clients, client contract partners, and/or regulatory agencies.
  • Submitting ICSRs to regulatory agencies in accordance with pre-determined documented distribution rules. This may include submissions by fax, email, courier or E2B.
  • Registering clients for and maintaining registrations of clients for electronic ICSR submissions to regulatory agencies.
  • Distributing ICSRs to clients or client contract partners in accordance with pre-determined documented distribution rules.
  • Participating as an active member of multidisciplinary teams to successfully achieve project and corporate goals. Identifying project issues and developing proposals for alternative strategies for discussion with superiors.
  • Mentoring less-experienced team members.
  • Other duties as determined. 

Qualifications:
-Education:  Completion of a life sciences degree (e.g. BSc, RN, MSc, PharmD). Advanced degree an asset (e.g. MSc, PhD).

-Experience: At least 5 years' experience within pharmacovigilance required

-Exceptional communications experience including written, verbal, and presentation skills.

-Minimum 4 (four) years' advanced work experience with all Microsoft Office Suite Products (Excel, Word, PowerPoint, Outlook) as well as other software and databases.
 
Knowledge/Skills/Abilities:
-Comprehensive experience in pharmacovigilance including knowledge of ICH, EEA, Good Pharmacovigilance Practices (GVP), US and Canadian legislation and regulatory guidance.

-Sound written and oral communication skills, good organizational and planning skills, and effective presentation skills to a variety of audiences.

-Ability to build positive, productive relationships with colleagues and clients.
 

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