The Fountain Group Hiring for Drug Safety Specialist at Upper Gwynedd, PA Full Time

Details for the position are as follows:

• 1 year assignment. Hybrid assignment(2 days/week onsite). Work Location: Upper Gwynedd, PA.
• 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 trainings.
• Experience with safety database.
• Experience with VEEVA Vault is a plus

Job Description:

• 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 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 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 s to ensure adherence to global case processing standards and regulatory requirements.
• Monitor group mailboxes utilized for the centralization of process/subject specific inquiries.

Required Skills:

• Bachelor’s degree 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.