Hendre Moolman at CK Clinical is currently recruiting for a number of Safety Risk Lead jobs with a Pharmaceutical company in Kent.
Working on a contract basis, as a Safety Risk Lead, you will performing proactive Safety Surveillance and Risk Management to effect product safety signal detection and evaluation, risk assessment and safety risk minimisation.
Key responsibilities of this Safety Risk Lead include:
- Safety Risk Leads (SRL) in Safety Surveillance and Risk Management (SSRM) will be the product “safety-management-team”, flexibly supporting all business units.
- Collaborate closely with the relevant Worldwide Safety Strategy VP Safety Strategy Business Unit/Research Unit Leads to support the appropriate BU safety strategies
- Provide and accumulate specific pharmacovigilance expertise, and applying this to various Business Units products assigned to the SRL
- Perform proactive Holistic Safety Review for products, across the span of relevant available safety data information.
- Reviews are incremental, cumulative and aggregate, to include the body of safety information
- Ensure Consistency of Safety Risk Messaging for a particular product or class of products, across multiple indications within the many safety reports and communications for that product.
- Provide suitable summaries of product risks to summary document authors where appropriate
- Perform ad hoc special activities, rapidly, to meet specific needs in the BUs, such as deliverables/emerging safety issue white papers/product Due Diligence Assessments
- Identify opportunities for Consistency and Standards for Safety Surveillance (SS) and Risk Management (RM) approaches and processes within and across BUs, and supporting the piloting and implementation of such
- Innovating, championing and implementing Novel Approaches across BUs:
- Engagement in Continuous Improvement initiatives, Safety Sciences Research & Communications activities, including methodological improvements
- -Engagement in inspection readiness and support.
- Provision of data to project managers for metrics and activity tracking
To be considered for this Drug Safety Lead position, you will have the following qualifications, skills and experience:
– MD, PhD, PharmD, DVM, MSc, or equivalents, and appropriate Pharma experience in SS & RM.
– Thorough understanding of Safety Risk Management internal and external environment, including applicable regulations and guidances.
– Displays a sound understanding of the scientific basis for therapies and drug-induced diseases. Comprehensive knowledge of drug development process.
– Clinical development and post-marketing experience to have an understanding of safetycontext across the drug lifecycle.
– Able to act independently, seeking guidance as appropriate. Demonstrates leadership in day-to- day activities and collaborative skills.
– Can handle more than one complex project simultaneously, prioritizing welland recognizing key issues.
– Ability in, and track record of, working effectively in an advanced matrix structure, including matrix team leadership/representation preferred.
– Recognizes other colleagues’ areas of expertise and utilizes them effectively to achieve team objectives. Runs effective meetings, including all colleagues’ diverse opinions and bringing group to consensus. Next steps and actions are clear.
– Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
– Relevant knowledge of Pharmaceutical Company organizational structure, policies, and practices, as applicable to safety Risk Management.