
Supervisor, Pharmacovigilance
2 days ago
Chennai, Tamil Nadu, India
ICON plc
Full time
₹ 9,00,000 - ₹ 12,00,000 per year
PV Supervisor ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Supervisor, Pharmacovigilance to join our diverse and dynamic team. As a Supervisor, Pharmacovigilance at ICON, you will play a pivotal role in overseeing the safety monitoring and reporting of adverse events related to clinical trials and marketed products. You will contribute to ensuring patient safety and regulatory compliance through effective management of pharmacovigilance activities, coordination with cross-functional teams, and maintaining the highest standards of safety reporting Roles & Responsibilities:- The Supervisor Pharmacovigilance supervises a subordinated group and oversees the related tasks. The Supervisor Pharmacovigilance supports creation and updates of SOPs, participates in departmental process and system improvement initiatives.
- Reviews project tasks performed by the group and provides leadership in the delivery of related services to clients.
- Is actively working on the tasks the subordinated job role performs as per the respective job description.
- Supervises case workflow.
- Assists or provides oversight with organization and planning of meetings, including preparation and distribution of presentations, agendas, and meeting minutes, as requested.
- Ensure adequate maintenance of SAE Hot Line, and other departmental phone lines, including documenting contacts and submitting to appropriate personnel.
- Recommends and supports implementation of performance and productivity improvements within the assigned service area to ensure optimal utilization of billable staff.
- Performs metric collection and data analysis to support company efforts for continuous improvement in policies, procedures, and business processes.
- Identifies and implements process improvements through review of SOPs, processes and recommends improvement plans to senior management.
- Participates in task forces to implement process improvement initiatives.
- Builds teamwork and improves process and productivity by working within and across functional areas.
- Creates an environment that encourages learning, self-improvement and career development for staff.
- Supports the development and implementation of training for the subordinated group or other personnel within the assigned service area.
- Supports direct reports and senior management during audit preparation and conduct. Responds to audit findings as needed.
- Develops company employees to ensure high quality work performance and retention of high-quality employees.
- Ensures staff development and performance feedback are provided through activities such as mentorship and career development.
- Communicates team/individual goals and expectations to ensure direct reports understand their responsibilities.
- Involved in the recruiting processes for new employees within the assigned service area.
- May serve as Local/Qualified Person for Pharmacovigilance (including deputy level).
- Directly supervises support-level staff and/or entry level professionals.
- Work is done independently and reviewed at critical points.
What You Will Be Doing:
- Supervising the day-to-day pharmacovigilance operations, ensuring timely and accurate reporting of adverse events.
- Collaborating with cross-functional teams, including clinical operations and regulatory affairs, to optimize pharmacovigilance processes.
- Ensuring compliance with global regulatory requirements and internal standard operating procedures for safety reporting.
- Managing safety data collection, analysis, and submission to regulatory authorities.
- Providing leadership and training to the pharmacovigilance team, ensuring adherence to best practices in safety monitoring.
- Bachelor's degree in life sciences, pharmacy, or a related field.
- Experience in pharmacovigilance or drug safety, with a focus on clinical trials or post-marketing surveillance.
- Strong knowledge of global pharmacovigilance regulations and guidelines.
- Excellent communication, leadership, and organizational skills, with the ability to manage a team effectively.
- Detail-oriented with the ability to manage multiple tasks and ensure accuracy in safety reporting.
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family's needs
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others