Drug Safety Specialist Jobs

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 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. • Represent PV on cross-functional initiatives to ensure PV SOP alignment and compliance. • 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.

Qualifications: Education: • Bachelor's degree or master's degree in a life science/healthcare/pharmaceutical related field. Required: • Candidate is required to have at least two years of pharmacovigilance safety experience or related areas such as Clinical Risk Management, Clinical or Regulatory. Software: • MS office suite • ARGUS and Veeva Vault is preferred. 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. • Demonstrates excellent written and communication skills. • Ability to manage and independently drive projects to completion Argus and Veeva Vault experience strongly preferred. Note: 1 year assignment. Hybrid assignment(3 days/week onsite).