Global Safety Services Manager

The Global Safety Services (GSS) Manager is responsible for the quality and compliance of all safety reporting deliverables, including individual safety reports and periodic safety reports. They will ensure timely and accurate tracking, site distribution, and regulatory submissions. They will support GSS Leadership in areas including pharmacovigilance processes development, KPIs/metrics, business development/budgets, and revenue recognition. The GSS Manager will provide training/mentorship to GSS Team members.

Responsibilities:

• Individual and Periodic Safety Reporting




• Responsible for ensuring quality and compliance of all reporting for which GSS is responsible, including individual case reports and periodic safety reports e.g. Development Safety Update reports (DSUR).
• Oversees all aspects of the PV reporting from project Start-up through Close-Out per the agreed scope of work.
• Monitors industry best practice and ensures safety reporting for studies, and relevant GSS processes, conform to all applicable global and local regulations and guidelines.
• Prepares and monitors safety metrics & Key Performance Indicators (KPI) related to safety reporting.
• Ensure GSS Safety activities are performed in compliance with all applicable regulations and Advanced Clinical standards.




• Support to GSS Leadership




• Assists in project specific audit/inspection preparation and actively participate in the audit/inspection.
• Investigates quality concerns, completes non conformances, and develops and implements Corrective and Preventive Actions (CAPAs) related to safety reporting as necessary.
• Escalates issues in a timely manner to GSS Leader.




• Business development - Supports GSS Leader with business development activities including proposals, slides, attendance at bid defense meetings, and budget development.
• Maintain knowledge of global regulatory authority regulations (FDA ,EMA, MHRA etc.)
• Participates in the development, review, and approval of departmental Standard Operating Procedures (SOPs).
• Represents Safety or ensures GSS representation at project team meetings and client meetings for clinical safety projects.
• Performs other work-related duties as assigned.

Qualifications:

• Bachelor's degree in healthcare, pharmacy or life science, or equivalent experience required.
• RN credentials or MD, preferred.
• Knowledge of Good Clinical Practices (GCPs), FDA and EMA regulations, ICH guidelines, global adverse event (SAE/NSAE) reporting requirements and reporting procedures for clinical trials and marketed products.
• Minimum 10 years of drug safety/pharmacovigilance experience including safety case processing, narrative writing, and safety report distribution/submission within a CRO or Pharmaceutical industry.
• Excellent knowledge of global and local PV regulations and legislation, both pre- and post-marketing.
• Strong project management, interpersonal, verbal and written communication skills.
• Familiar with Safety Databases (ARGUS, Veeva Safety, ARISg, LifeSphere)
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, MS Project), email, and internet.
• Experience with regulatory authority inspections
• Able to work with a high level of autonomy and independence
• Ability to be flexible, adapt to change, work independently, as well as part of a team in a matrix environment.

Role Competencies:

• Maintains a focus on key priorities and deliverables, staying resilient in the face of pressure. Uses challenges and new situations as an opportunity to learn and improve. Understands own "facts" and "stories" when in dialogue, and the impact leadership style can have on outcomes.
• Actively listens and learns from others, demonstrating patience and consideration for others' concerns or frustrations. Asks questions for clarification and ensures message is understood. Takes time to digest what is heard before responding.
• Visible, approachable, and accessible. Encourages input and participation from colleagues to solve problems and innovate. Provides correct balance of direction and support to staff and colleagues according to each situation. Understands differences, anticipates areas of conflict and takes action.
• Evaluates and measures current processes. Works with a view of the future, prioritizing work in line with organizational objectives. Improves processes to maximize use of resources.
• Seeks opportunities to develop professional skills and knowledge and encourages team to do so. Supports and directs where appropriate, including recognizing achievements and providing constructive feedback and guidance. Cross-train others to broaden experience and develop potential.
• Translates major new directives into individual performance expectations. Explains and convinces others of the need for adaptation and change of policies, structures, and methods.
• Is comfortable facing issues with team members quickly and directly. Is willing to choose an approach that has not been tried before, or a leadership style that feels less comfortable if the situation demands it. Takes personal risks regularly and is not afraid to express bold opinions if the intention and motive is good. Holds self and team accountable to upholding the REAL values.
• Consistently reflects the REAL values and inspires team to live and work by these values.

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research - approaching each opportunity with foresight, character, resilience and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.