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Integrated Resources, Inc ( IRI ) Hiring for Drug Safety Specialist at Pennsylvania, United States Full Time
Title- PV Specialist
Location: Hybrid assignment (2 days/week onsite); Work Location: Upper Gwynedd, PA
Duration: 12 Months
Job Requirements–
- Developing and maintaining documents outlining the processes to ensure high quality individual case and aggregate safety ing 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 training.
- Process incoming communications from internal and external sources and initiate appropriate course of action and/or response.
- Perform quality review of expedited and periodic s to ensure adherence to global case processing standards and regulatory requirements.
- Monitor group mailboxes utilized for the centralization of process/subject specific inquiries.
- Documentation and training role.
- Writing SOP’s – we are responsible for maintaining Individual Case Safety (ICSR)and aggregate ing.
- More focus is on the Individual Case Safety (ICSR).
- Familiarity with any Learning management system. Experience with My learning system is a plus.
- Need someone who can deliver and create training.
- Experience with safety databases.
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.
- Software: MS office suite and Veeva Vault is preferred.
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Apply For This JobJob Overview
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ID: 393587
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Date Posted:
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Location: Pennsylvania, United States
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Job Title: Integrated Resources, Inc ( IRI ) Hiring for Drug Safety Specialist at Pennsylvania, United States