13 Aug
|
ClinChoice
|
Bengaluru
13 Aug
ClinChoice
Bengaluru
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 regulation
📌 Director - Aggregate Reporting, Risk Management & Surveillance (ARRMS) (Bengaluru)
🏢 ClinChoice
📍 Bengaluru