Director - Aggregate Reporting, Risk Management & Surveillance (ARRMS)
ClinChoiceRemote · Posted 3 months agoDescription
Job Title: Director - Aggregate Reporting, Risk Management & Surveillance (ARRMS)
Employment Type: Full time
Location: Bengaluru
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, Poland, Italy 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.
Primary Responsibilities:
Strategic Leadership & Process Optimization:
- Establish and optimize processes, tools, and frameworks to enhance efficiency, quality, and compliance in aggregate reporting, surveillance and risk management
- Drive innovation to streamline operations and improve regulatory
Team & Performance Management:
- Lead, mentor, and manage a team of safety scientists, report writers, safety physicians, and quality reviewers.
- Oversee resource planning, workload management, and performance tracking to ensure efficiency and talent
- Champion a culture of quality and compliance, ensuring robust peer reviews and adherence to
Regulatory Compliance & Quality Oversight:
- Oversee the end-to-end production and quality review of Global and local aggregate reports (for example, PBRER/PSUR, DSUR, RMP, PADER, CAR, MDR PSUR, Cosmetovigilance reports ).
- Ensure compliance with major PV regulations such as but not limited to ICH, GVP, FDA, EU MDR, and Health Canada regulatory
- Identify and mitigate risks impacting timelines, quality, or regulatory
Client & Stakeholder Engagement:
- Act as the primary PoC for key sponsors, managing expectations and ensuring seamless
- Drive client satisfaction by addressing concerns, implementing feedback-driven improvements, and maintaining compliance.
- Represent the organization in client meetings, audits, and regulatory discussions to strengthen
Business Growth & Thought Leadership:
- Support business development through proposal responses, client presentations, and service expansion strategies.
- Contribute to white papers, webinars, and industry thought leadership to enhance the organization's reputation.
- Provide data-driven insights through dashboards, trend analysis, and performance reports.
Operational Excellence & Compliance:
- Ensure adherence to sponsor SOPs, templates, and guidelines across
- Oversee SLA/KPI compliance, drive process improvements, and manage escalations
- Lead and support internal and external audits, ensuring timely resolution of
- Manage aggregate reporting and surveillance projects to ensure compliance with safety regulations and guidelines.
- Manage the day-to-day operations within project and liaise with the team and management to ensure effective functioning of the team and address any concerns or issues.
- Ensure a ‘true global’ model in place through collaboration with regions around the globe to adapt best practices and consistent approach throughout customer’s business.
- Management of continuous improvement plans to optimize margin and minimize variable expenses.
- Ensure compliance with appropriate contract Change Management practices.
- Provide regular reports to the Director of Safety regarding project performance, metrics, and updates.
- Ensure Business Continuity has been planned and is operationalized when the need arises
Secondary Responsibilities:
Service Enhancement & Capability Building:
- Enhance workflows and efficiencies by developing new services, streamlining processes, and improving reporting accuracy.
- Establish best practices through SOPs, templates, and work instructions for
- Drive team capability development via structured training programs, knowledge- sharing initiatives, and
- Strengthen talent pipelines through mentorship programs and succession
- Identifying opportunities to develop and implement technologies or automations to enhance the project performance based on client’s requirements.
Talent & Resource Management:
- Lead hiring and workforce planning, ensuring alignment with business
- Foster a high-performance culture with structured career development.
- Collaborate closely with Line managers and leadership team for strategizing and implementing the organizational initiatives for talent development and onboarding.
Skills & Qualification:
- Graduate or Post-Graduate in Life Sciences or Healthcare discipline, or its equivalent, in alignment with project/role/business requirements.
- 15+ years’ experience relevant for domain/ business requirements, and/or appropriate expertise/knowledge evaluated via specific assessments.
#LI-SN1 #LI-Remote #LI-Director #LI-FULLTIME
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