Manager, Surveillance & Risk Management Consultant

Full-time - Mid Level

NJ

About the position

ClinChoice is searching for a Manager, Surveillance & Risk Management Consultant to join one of our clients. This role will support US Operating Company Pharmacovigilance oversight to ensure that internal and external organizations are compliant with Pharmacovigilance regulatory requirements, as part of the conduct of non-interventional studies and patient support programs.

Responsibilities

• Review open RRAs (Related Research Activities) to create a listing of non-compliances
• Work with Buyer to establish processes for addressing different areas of non-compliance
• Review RRAMS data and remediate training for those RRA team members that have not completed AE/PQC training
• Review RRAMS data to identify contracts without PV exhibits and escalate to Buyer for remediation
• Routinely liaise with internal and external partners to complete required activities
• Support the close out of RRAs
• Ensure the Pharmacovigilance (PV) Provider training process, PV review of market research, and noncompliance process are conducted and documented per defined procedures
• Ensure relevant study documents are in the correct repository per the defined procedures
• Perform other duties as required to support the other team members
• Communicate and collaborate with other stakeholders as needed

Requirements

• BS degree
• 2-3 years of pharmaceutical industry experience required
• Pharmacovigilance/Pharmacovigilance compliance experience preferred
• Attention to detail
• Strong communication skills
• Ability to assess information, identify discrepancies, and execute compliance tasks to meet procedural requirements
• Experience with software tools, particularly spreadsheets and databases, managing data and reports