The Reference Safety Document Lead collaborates across business units and functional lines to ensure that Investigator's Brochures (IBs) are created, revised, maintained, and submitted in compliance with governing SOPs and regulatory requirements. The role also has responsibility for tracking and releasing Single Reference Safety Documents (SRSDs) for use by client's drug safety analsysts and clinical trial investigators. The RSD Lead will be accountable for contributing to relevant initiatives, continuous improvement projects and technology advancements aimed at ensuring the effective management and/or delivery of all reference safety documents used in clinical trials. This is a home-based position.
Managing Single Reference Safety Documents (SRSDs) associated with clinical trials by:
- Monitoring for updates to their Reference Safety Information (RSI)
- Maintaining appropriate versions for availability by drug safety teams, and
- Communicating all updates to clinical investigators
Provide overall management of the creation and maintenance of Investigator Brochures, by:
- Chairing or co-chairing IB meetings, and leading team discussions to establish appropriate strategy for the IB.
- Providing end-to-end project management of the IB deliverable, setting clear targets and ensuring all functional lines are aware of commitments, securing necessary contributions, and completing within agreed timelines.
- Ensuring full execution of all IB documents (initial creation and updates) in compliance with ICH guidance, regulations and internal policies.
- Interpreting and advising current regulations/guidances considering the wide range of needs of various internal stakeholders.
- Leading IB contributing teams through issues and barriers to achieve timely and quality resolution.
Contribute to the broader needs of the Reference Safety Document Management team by:
- Understanding roles, responsibilities and dependencies of upstream and downstream stakeholders and deliverables.
- Evaluating current systems and processes and offering suggestions for improvements.
Ensure all actions taken within role follow applicable policies, SOPs and associated documents so that high quality delivery of outputs and compliance is maintained.
Bachelors degree in Life sciences, pharmacy graduate or equivalent. Advanced academic qualifications/degree an advantage.
Experience & Attributes
3-5 years of pharmaceutical, regulatory, or clinical experience:
- Must have experince understanding of the dynamics and purpose of a company Investigators Brochure and core function of SRSD management
- ‘Hands on' pharmaceutical experience associated with content development and maintenance within the area of Medical Affairs, Drug Safety, or Regulatory Affairs
- Knowledge of overall drug development process and experience with regulated deliverables.
- Basic Pharmacovigilance knowledge desirable.
- Knowledge of ICH, CIOMS and key markets regulations and requirements.
- Proven leadership in leading global teams through consistent execution and delivery. Demonstrated ability to build and foster strong matrix team working relationships across global setting.
- Project management skills with a focus on quality and compliance. Skilled in managing and delivering multiple projects on time despite competing priorities and conflicts.
- Ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy. Demonstrated ability to influence and negotiate despite having a wide and diverse set of stakeholders.
- Proven ability to make sound decisions and seek to resolve problems in a proactive manner.
- Proven effective written and oral communication.
- An understanding of medical terminology.
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