<p style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong>Job Title: </strong><strong>Director</strong><strong> - Aggregate Reporting, Risk Management & Surveillance (ARRMS)</strong></span></p>
<p style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong>Employment Type: Full time </strong></span></p>
<p style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong>Location: Bengaluru</strong></span></p>
<p style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong><u>About ClinChoice </u></strong></span></p>
<p style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">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.</span></p>
<p style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">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.</span></p>
<p style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">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.</span></p>
<p style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong><u>Primary Responsibilities:</u></strong><strong> </strong></span></p>
<h3 style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"> <span style="text-decoration: underline;">Strategic Leadership & Process Optimization:</span></span></h3>
<ul>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Establish and optimize processes, tools, and frameworks to enhance efficiency, quality, and compliance in aggregate reporting, surveillance and risk management</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Drive innovation to streamline operations and improve regulatory</span></li>
</ul>
<h3 style="line-height: 1;"><span style="text-decoration: underline;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Team & Performance Management:</span></span></h3>
<ul>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Lead, mentor, and manage a team of safety scientists, report writers, safety physicians, and quality reviewers.</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Oversee resource planning, workload management, and performance tracking to ensure efficiency and talent</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Champion a culture of quality and compliance, ensuring robust peer reviews and adherence to</span></li>
</ul>
<h3 style="line-height: 1;"><span style="text-decoration: underline;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Regulatory Compliance & Quality Oversight:</span></span></h3>
<ul>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">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 ).</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Ensure compliance with major PV regulations such as but not limited to ICH, GVP, FDA, EU MDR, and Health Canada regulatory</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Identify and mitigate risks impacting timelines, quality, or regulatory</span></li>
</ul>
<h3 style="line-height: 1;"><span style="text-decoration: underline;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Client & Stakeholder Engagement:</span></span></h3>
<ul>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Act as the primary PoC for key sponsors, managing expectations and ensuring seamless</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Drive client satisfaction by addressing concerns, implementing feedback-driven improvements, and maintaining compliance.</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Represent the organization in client meetings, audits, and regulatory discussions to strengthen</span></li>
</ul>
<h3 style="line-height: 1;"><span style="text-decoration: underline;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Business Growth & Thought Leadership:</span></span></h3>
<ul>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Support business development through proposal responses, client presentations, and service expansion strategies.</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Contribute to white papers, webinars, and industry thought leadership to enhance the organization's reputation.</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Provide data-driven insights through dashboards, trend analysis, and performance reports.</span></li>
</ul>
<h3 style="line-height: 1;"><span style="text-decoration: underline;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Operational Excellence & Compliance:</span></span></h3>
<ul>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Ensure adherence to sponsor SOPs, templates, and guidelines across</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Oversee SLA/KPI compliance, drive process improvements, and manage escalations</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Lead and support internal and external audits, ensuring timely resolution of</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Manage aggregate reporting and surveillance projects to ensure compliance with safety regulations and guidelines. </span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">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. </span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">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. </span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Management of continuous improvement plans to optimize margin and minimize variable expenses. </span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Ensure compliance with appropriate contract Change Management practices. </span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Provide regular reports to the Director of Safety regarding project performance, metrics, and updates.</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Ensure Business Continuity has been planned and is operationalized when the need arises</li>
</ul>
<p style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong><u>Secondary Responsibilities:</u></strong></span></p>
<h3 style="line-height: 1;"><span style="text-decoration: underline;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Service Enhancement & Capability Building:</span></span></h3>
<ul>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Enhance workflows and efficiencies by developing new services, streamlining processes, and improving reporting accuracy.</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Establish best practices through SOPs, templates, and work instructions for</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Drive team capability development via structured training programs, knowledge- sharing initiatives, and</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Strengthen talent pipelines through mentorship programs and succession</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Identifying opportunities to develop and implement technologies or </span>automations to enhance the project performance based on client’s requirements.</li>
</ul>
<h3 style="line-height: 1;"><span style="text-decoration: underline;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Talent & Resource Management:</span></span></h3>
<ul>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Lead hiring and workforce planning, ensuring alignment with business</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Foster a high-performance culture with structured career development.</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Collaborate closely with Line managers and leadership team for strategizing and implementing the organizational initiatives for talent development and onboarding.</li>
</ul>
<p style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong><u>Skills & Qualification: </u></strong></span></p>
<ul>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt; line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Graduate or Post-Graduate in Life Sciences or Healthcare discipline, or its equivalent, in alignment with project/role/business requirements.</span></li>
<li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt; line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">15+ years’ experience relevant for domain/ business requirements, and/or appropriate expertise/knowledge evaluated via specific assessments.</span></li>
</ul>
