Pharmacovigilance

Pharmacovigilance Safety Specialist

Education: Bachelor's degree or Master's degree or Advance level degree in a life science/healthcare/pharmaceutical related field.

Required: Candidate is required to have at least 2 years of pharmacovigilance safety experience or related areas such as Clinical Risk Management, Clinical or Regulatory preferred. Strong knowledge base of pharmacovigilance principles with close attention to detail and ability to be flexible in order to meet daily competing priorities of the business. Ability to independently contribute effectively to group projects, handle individual tasks, and take initiative when necessary. Veeva Vault experience preferred.

Software: MS office suite. Veeva Vault is preferred.

Personality: Detail Oriented. Able to work independently. Team Player. Excellent written and verbal communication skills.

Note: 1 year assignment. Hybrid assignment (2 days/week onsite). Work Location: Upper Gwynedd, PA.

Responsibilities:

We are looking for (2) Contractors to support PV Operations and Global Process Enablement in Documentation and Training and PV Quality and Compliance with responsibilities to include:

• Documentation, training, and global standards team within client in need of a supportive and highly motivated individual within their team that will assist in developing and maintaining documents outlining the processes to ensure high quality individual case and aggregate safety reporting in accordance with pharmacovigilance (PV) policy and regulations.
• Assist in the management and maintenance of PV-controlled documents (e.g. Global Safety Database User Manual, Standard Operating Procedures, and training material).
• Assist in the authoring, reviewing and implementation of new PV-controlled SOPs and supportive documents.
• Assist in reviewing, creating, and delivering trainings.
• Process incoming communications from internal and external sources and initiate appropriate course of action and/or response.
• Perform quality review of expedited and periodic reports to ensure adherence to global case processing standards and regulatory requirements.
• Monitor group mailboxes utilized for the centralization of process/subject specific inquiries.

Comments/Special Instructions:

Documentation and training role. Writing SOP's-we are responsible for maintaining Individual Case Safety Report (ICSR) and aggregate reporting. More focus is on the Individual Case Safety Report (ICSR). Familiarity with any Learning management system. Experience with My learning system is a plus. Someone who can deliver and create trainings. Experience with safety database. Experience with VEEVA Vault is a plus.