Safety Lead Risk Management Consultant

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Benefit Risk and Risk Management Lead Consultant for 12 months Contract with possibility of extension to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality professional development and supportive culture. As a client-facing role we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.

Job Description

Job Title: Benefit Risk and Risk Management Lead

Employment Type: Contract

About ClinChoice

ClinChoice is a partner to the largest pharmaceutical medical device and consumer care innovators in the world. Established in 1995 we provide expertise in clinical operations biometrics regulatory affairs pharmacovigilance medical affairs and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights delivering the best strategies for product registration and enhancing patient safety through real-world and clinical analysis.

Our global delivery network has expanded to centers and satellite offices in the United States Mexico United Kingdom Armenia China Japan India and the Philippines to help our customers maintain regulatory compliance locally and globally.

We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision.

Summary

The Benefit Risk and Risk Management Lead is accountable for the global medical safety management of products and informs a robust understanding of the benefit-risk profile portfolio assesses and reviews risk assessment/risk minimization activities as well as additional pharmacovigilance activities and if needed signal detection and evaluation to ensure products are safe for patients.

Responsibilities:

This leader will provide leadership and strategic insight and input into the following areas:

• Lead contribute to and/or execute proactive safety surveillance and risk management activities including product safety signal detection evaluation risk assessment and risk minimization.

• Contribute to benefit–risk assessments in partnership with other benefit–risk management functions.

• Independently evaluate safety data from all sources identify and analyze safety signals and present medical assessments and benefit–risk evaluations to relevant committees and forums.

• Develop independent action plans to address safety risk and benefit–risk issues frequently coordinating cross-functionally to implement risk minimization strategies.

• Review and approve safety documents including those related to product benefit–risk profiles.

• Ensure consistent safety and risk messaging for a product or product class across indications and business units.

• Apply a strong understanding of aggregate safety data signal detection methodologies and benefit–risk assessment processes.

• Conduct comprehensive safety data reviews safety assessments clinical safety signal identification and risk identification and management.

• Synthesize data to support informed benefit–risk decisions.

• Demonstrate knowledge of global safety and regulatory issues relevant to clinical research and drug development.

• Serve as the safety point of contact for Asset Teams and when needed chair appropriate Risk Management Committees.

• Apply solid understanding of therapy mechanisms and drug-induced disease processes.

• Lead cross-functional teams effectively modeling commitment and enthusiasm in a matrixed environment with minimal oversight.

• Exhibit strong scientific and medical expertise including proficiency in interpreting medical literature.

• Communicate clearly and effectively both verbally and in writing.

• Fulfill additional responsibilities as required by evolving project needs.

• Work collaboratively within a matrix organization across multiple time zones.

Candidate Profile

• Medical Degree or equivalent or a Healthcare professional preferably with a postgraduate degree (Master’s PhD or equivalent) in Pharmacy Life Sciences or a related discipline.

• Minimum of 6 years of experience specifically in pharmacovigilance risk management.

• Strong understanding of safety risk management principles and the relevant internal and external regulatory landscape including applicable guidelines.

• In-depth knowledge of pharmacovigilance regulations and requirements for the assigned geography.

• Comprehensive understanding of the drug development process and post-marketing activities with awareness of safety considerations throughout the product lifecycle.

• Proven ability to influence and collaborate with internal and external stakeholders.

• Ability to work independently while seeking guidance appropriately; recognizes and effectively leverages the expertise of colleagues to achieve team goals.

• Demonstrated leadership strong interpersonal skills and experience working collaboratively in cross-functional environments.

• High level of business ethics integrity and professionalism.

• Strong communication skills with fluency in English.

• Knowledge of good documentation practices with strong attention to detail and accuracy.

• Self-motivated proactive and able to work independently with a strong “can-do” attitude.

• Global mindset preferably with experience working in a multinational pharmaceutical organization.

• Adaptable and resilient in a dynamic environment with the ability to manage multiple projects simultaneously.

Key Words: Risk Management PV Risk Management Risk assessment

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