Manager, Safety Submissions (Clinical Trials)
Precision for Medicine
Precision for Medicine have an exciting opportunity for a Manager, Safety Submissions / Reporting to join our team This position is based remotely in India.
Precision for Medicine is a precision medicine CRO. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.
Responsible for oversight of Safety submission including management and development of safety submissions staff, development and maintenance of SOPs, and the development of project specific reporting plans for the processing and global reporting of expedited and periodic reports associated with clinical trials and/or post-marketing safety surveillance. Provides line management to direct reports including training, performance management, professional development, and coaching.
Essential functions of the job include but are not limited to:
- Participate in the set-up and development of monitoring tools and maintenance of submissions workflow within the global safety database to meet global regulatory reporting requirements.
- Oversee the internal submissions process for all destinations including regulatory bodies, ethics committees, research board, clinical trial investigators, partners and internal departments
- Track and monitors all submission timelines to ensure that submissions are compliant with the regulatory requirements.
- Identify/anticipate roadblocks and help identify solutions to support the scheduling and timelines of major regulatory submissions.
- Ensures the accuracy and completeness of electronic and hard copy regulatory submissions.
- Provides support during interactions with regulatory agencies reviewing submission content.
- Identify root causes for late ICSR submissions and implementation of appropriate corrective actions
- Actively manage the safety report scheduling and timelines. Track and maintain compliance with regulatory timelines and submission requirements.
- Assess impact of new regulations
- Generate and use established reports to monitor daily case workload and reports due, working with team members to identify potential bottle necks or resource gaps and coordinate work plans accordingly
- Develop global Safety Reporting Plan
- Provide line management to direct reports, including training, performance management, professional development and coaching
- Maintain project and submission projections for functional planning on assigned products.
- Serve as primary contact for forecasting of global regulatory project and submission activity for strategic planning and resourcing planning purposes to ensure adequate product support.
- Plan and manage detailed project and submission timelines; provides reporting on timeline status to key stakeholders.
- Proactively raise project timeline concerns, risks and issues that may delay/impact the project and presents risk mitigation strategy.
- Keep abreast of emerging and shifting regulatory environment; communicates to department leadership.
- Evaluate project and product processes and learnings across programs and recommends process changes; ensures process changes are implemented.
- Excellent communication skills, both written and oral
- Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
- Knows how/when to apply organizational policy or regulatory procedures to a variety of situations.
- Ability to work under pressure in order to meet tight timelines
- Ability to provide direction to a team, and to influence peers and team members appropriately
- Demonstrated competence in obtaining, analyzing, disseminating, and reporting safety information in compliance with global regulations
- Bachelor’s degree or higher in Health/Biomedical Sciences related field or other relevant
- Clinical Trial experience
- Other Required:
- 5 years of experience in safety in the CRO or pharmaceutical industry
- 2 years of experience in a leadership capacity in a relevant area
- Solid knowledge of FDA and EMA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations.
- Experienced in EMA EudraVigilance administration and submissions, ToetsingOnline, UK MHRA ICSR/DSUR Submissions, EMA CESP portal and other submissions portals
- Experience of ARGUS safety database
- Work effectively as a team member and promotes collaboration
- Demonstrate ownership, initiative and accountability
- Supervisory experience
- Ability to deliver on commitments and understanding of service culture
- Communicates effectively and efficiently on safety issues to internal and external stakeholders
- Maintain consistency of safety assessments
- Serve in cross-functional teams as Drug Safety expert re. safety regulatory intelligence
- Monitor regulatory compliance of safety reporting throughout trial
- Lead or contribute to process development and/or process improvements that support Drug Safety
Precision medicine is revolutionizing the attack on cancer—and we are passionate about helping you harness its power. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC