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
* and analysis.
* Staff training and mentoring.
* Monitor performance of direct reports and provide constructive feedback
* 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
* 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 North America and 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
* Supervisory experience
* Solid understanding of all aspects of medicinal product project life-
* 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
* 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
* 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 (e.g. French/Spanish/Russian) or Asian
* 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.
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Location/Region: Carlsbad, CA