• The experienced Pharmacovigilance/Drug Safety Senior Manager would be responsible for leading and conducting complex process/system audits, affiliate/local operating company audits, and Contract/License Service Providers in areas such as drug safety, risk management, REMS.
• Must be able to work diligently both within a global team setting and individual in the US New Jersey headquarters.
• Audits will involve global travel, and process/system audits include such areas as aggregate reporting, signal detection, case processing, and Market Research.
• There will also be overlap in the PV audit program with GCP (e.g. Investigator brochure, IIT processes), GMP (Product recall process, Medical Affairs) and CSV (ARISg database review).
• On average, the Senior Manager will be required to conduct approximately 6-8 audits each year, in addition to involvement in other compliance initiatives.
Summary / Scope:
• Plans, conducts and follows up on GxP audits of assigned entities to assess compliance with regulatory and internal requirements; identify compliance risks and drive concurrence regarding their severity
• Contribute to planning and operational analyses for discipline
• Scope includes internal and external audits of global sites/affiliates, processes and vendors
• Serves as a subject matter expert within the unit.
• As the lead, plans and executes highest risk, most complex audits/compliance projects under minimal supervision. As a team member, independently executes high risk elements of the audit/compliance projects.
• Must be able to multi-task required work for the role, in addition to ad-hoc / department projects.
• Supervises and provides guidance to unit colleagues beyond just a team/audit/project setting.
• May mentor colleagues and be viewed as a leader/mentor.
• Demonstrates the ability to multi-task responsibilities.
• Assists in the development of the annual audit plan (where applicable).
• Assists in the development of the department training plan; trains and develops junior staff.
• May provide guidance / recommendations to clients re business practice or compliance issues.
• Provides input to audit/inspection criteria, programs, and plans.
• Maintain audit database for observations and audit CAPA.
• Contribute to the development and implementation of Standard Operating Procedures
• Minimum of Bachelors Degree
• Ten (10) plus years of relevant GxP pharmaceutical/biotechnology industry experience, including minimum four (4) to six (6) years of compliance related or auditing experience (or equivalent)
Key Requirements :
• Advanced subject matter expert in the required technical knowledge and expertise.
• Ability to analyze emerging compliance issues and recommend strategies to manage compliance risks.
• Travel: Position requires about 25% domestic and international travel.