Safety Manager - Clinical Trials Services - Remote [O-355]Pubblicato il 02-10-2020 - Clinical Solutions in Milano Provincia
This highly visible role combines your clinical drug safety operations and project launch experience with your
project management expertise.
The Safety Manager provides leadership, management and general oversight and direction for clinical trials,
pharmaceutical/biological product safety reporting and related activities.
The Safety Manager may be involved in other therapeutic and product areas and post-marketing safety reporting
Responsibilities include oversight of drug safety operations including management and development of safety
staff, development and maintenance of project specific Safety Management Plan (SMP) and safety department
Standard Operating Procedures (SOPs),
case quality and reporting evaluation and compliance, client satisfaction,
adequate resource planning and allocation, and project financial performance and team performance.
Essential functions of the job include but are not limited to:
Management, support, direction, coordination and planning for drug safety reporting and related activities.
Strategic input, including providing subject matter expertise for drug safety services in the planning, setup,
maintenance and closure of projects, including costing, budgeting, resourcing, workflow and process design
Staff training and mentoring.
Monitor performance of direct reports and provide constructive feedback and coaching.
Liaison with internal (e.g. business operations, account management) and external stakeholders (e.g.
clients, third party vendors, health authorities, business partners).
Represent Safety if and when required for internal and external matters.
Provide support in internal and external audits and inspections and ensure that corrective actions are
implemented as appropriate.
Prepare and/or review project‑specific SMP
Assist with clinical trial case processing and QC and other activities as needed
Review and update proposals (RFP), budgets and contracts as required.
Represent safety during bid-defense meetings
Minimum of 5 years of experience in clinical trial drug safety in the Pharma/CRO industry,minimum of 2
years in Manager/Lead role in drug safety or equivalent.
Degree in Pharmacy or Nursing preferred, but other Life Science, or other health-related field, or equivalent
Excellent knowledge of European drug safety and regulations, drug development, and
ability to apply global safety regulations
Proven track record of developing client relationships and functioning as a subject matter expert
Experience with Oracle Argus Safety Database
Proven ability to review and manage the safety budget
Solid understanding of all aspects of medicinal product project life-cycle
Resource planning and strategy.
Development and maintenance of Safety Department SOPs
Communicates and collaborate effectively and efficiently on safety issues to internal and external
Ability to deliver on commitments and understanding of service culture
Maintain consistency of excellent safety assessments. In accordance with departments SOP and guidelines
Serve in cross-functional teams as Drug Safety expert.
Attend and/or lead safety operations discussions during client meetings
Monitor regulatory and quality compliance of safety reporting throughout trial.
Lead or contribute to process development and/or process improvements that support Drug Safety
Experience in evaluation of safety data and the preparation of safety reports (Individual and aggregate safety
reports in accordance with ICHE2A and C)
Customer focus, commitment to quality management and problem solving
Effective communication and negotiation skills
Proven Ability to:
Build effective project teams, motivate, delegate, and drive timely/quality decision-making and operational
Gain trust and confidence with a variety of clients and within Precision
Create a sense of urgency and take a proactive, solutions-based approach
Prioritize and manage multiple, varied tasks with enthusiasm and attention to detail
Thrive in a matrix environment and to value the importance of teamwork
Work independently with limited oversight guidance
Experience in ICHE2D, E and EMA GVP
Early phase oncology clinical trial experience
Experience with managing safety database transition/migration
Fluency in major European language
Demonstrates excellent scientific/clinical or analytical knowledge base, with ability to assess data and
understand the safety/medical or process implications.
Demonstrates excellent verbal and written communication skills.
Strong critical thinking, problem solving and decision-making skills
Excellent attention to detail, teamwork and initiative.
Able to plan effectively to create, update and maintain core safety documents in a timely manner.
High level of IT skills in Microsoft Office products.
Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics, clinical trial delivery, and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.