US - Safety Specialist

Position Overview

Please note:

in line with
*** policy, this role is VDI only.
*** will not be providing a laptop or equipment.

May be extended until end of December.

Under supervision of the Deputy LSO US - Operations Lead, the individual is responsible for contributing to daily activities to ensure a compliant Pharmacovigilance (PV) system in order to safeguard public health and maintain compliance with applicable regulatory requirements.

The Safety Specialist reports primarily to the Deputy LSO US - Operations Lead and supports the US Safety team with local PV deliverables and administrative duties during maternity leave and system transitions.

• Managing US postal follow-up activities.
• Addressing affiliate queries independently.
• Supporting product management documentation.
• Assisting with PV training.
• Maintaining safety documentation and compliance with drug safety regulations.

• Compliance with PV follow-up activities and effective communication skills.
• Ensure compliance in postal follow-up activities and provide necessary team support in the coming year.

• Supporting routine Pharmacovigilance Operations by managing the fulfillment activities for US postal follow-up letters and independently liaising with the US mailroom as required.
• Independently address queries raised by affiliate/global follow-up team in accordance with internal procedures.
• Product Management team activities:
  Provide administrative support liaising with marketing team project/program owners to ensure proper documentation is in place, in accordance with SOPs, for programs with Pharmacovigilance impact, and ensure timely updates to the various tracking tools.
• Provide back-up and administrative support as required as US affiliate transitions to the new safety database.
• Support US team in providing Pharmacovigilance Training to vendors/in house personnel as required.
• Support with proper archival of US Safety documentation/forms.
• Maintain current knowledge of drug safety regulations and procedures.
• Other responsibilities and projects as assigned by manager/company.

Experience

• Bachelor’s Degree.
• Education in a health-related area highly preferred as well as basic knowledge with the medical terminology.
• Minimum 1-2 years of Pharmacovigilance Experience preferred or advanced clinical degree (RN, Pharm
  
  D) in lieu of direct PV experience.
• Some understanding of Pharmacovigilance and related obligations.

Specific skills

• Creative and persistent problem solver. Recognize areas of process improvements related to the function and provide feedback to management.
• Takes ownership of meeting high standards.
• Ability to prioritize, organize and plan.
• Proficiency with safety databases, MS office applications.
• Ability to network and effectively communicate with international teams.
• Proactive and independent problem solver.
• Quality oriented.
• High level of creative and innovative thinking.

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”