Associate Director, Pharmacovigilance (PV) Operations

remote click jobs; India; On-site; INR 3,500,000 - 7,500,000; Full time

Job summary

reputed company, a biotech focused on oncology, is seeking an Associate Director of PV Operations to oversee outsourced ICSR processing and ensure compliance with Safety SOPs. You will serve as the primary PV contact for the case processing vendor and work with PV physicians, PV scientists, and cross-functional teams as we expand toward potential market authorization.

Reporting to the Senior Director of PV Operations, you will monitor vendor performance, drive safety reporting, support SAE

Qualifications

• Bachelor's degree in nursing, RN, Pharmacy, Pharm D., or other relevant health-care field.
• 8-10 years of experience in biotech/pharma environments.
• Experience with pharmacovigilance operations and regulatory requirements (GVP).
• Strong vendor management and cross-functional collaboration skills.

Responsibilities

• Manage relationships with safety vendor(s) to ensure effectiveness, quality, and compliance of outsourced activities.
• Sponsor operational safety responsibilities and ensure accurate execution of safety processes.
• Monitor vendor performance and IC SRs, providing feedback and training as needed.
• Monitor KPIs of case processing and present findings to Head of PV and stakeholders.
• Participate in daily management and execution of safety tasks for assigned clinical programs.
• Review incoming adverse event reports and oversee expedited safety submissions when required.

Skills

PV Operations leadership

Vendor management

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree in nursing, RN, Pharmacy, Pharm D., or other health-care field

Job description

reputed company:With deep expertise in reputed company, reputed company is working to create selective medicines designed with the goal to address the needs of patients with cancer. reputed company is an exciting early-stage company, bringing together reputed company scientists and industry veterans with a proven reputed company record in drug discovery, oncology drug development, and company building.

The Role:

Reporting to the Senior Director of Pharmacovigilance (PV) Operations, the Associate Director of PV Operations will reputed company vendor reputed company and review of ICSR processing. They will ensure compliance and adherence to Safety processes and SOPs as reputed company as manage and analyze data from the Global Safety Database. This SME will be the primary reputed company of contact for reputed company reputed company of the case processing vendor. They will work in reputed company collaboration with PV physicians, PV scientists, and PV reputed company on operational safety and case reputed company issues The role will expand and reputed company in line with reputed companys expansion as we approach potential market authorization.

Responsibilities

• Manage and support the relationship with safety vendor(s) to ensure effectiveness, reputed company and compliance of reputed company outsourced activities.
• reputed company Sponsor reputed company of operational safety responsibilities, including the reputed company and accurate execution of the processes defined reputed company the applicable Safety Management plans.
• Monitor performance (metrics, other reports) of the safety vendor and the reputed company reputed company of the IC SRs; reputed company appropriate feedback and training.
• Monitor key performance indicators of case processing and present findings to Head of PV and cross-functional stakeholders.
• Participate in daily management, operational reputed company and execution of operational safety tasks for assigned reputed company clinical programs.
• As needed. review incoming adverse event reports and communications from vendors to determine reputed company required and ensure reputed company review, follow-up, and reputed company submission of expedited safety reports.
• reputed company case workflow (case receipt through submission) between safety vendor and reputed company Pharmacovigilance team.
• Ensure safety case queries are resolved as per defined processes (interfacing with safety physicians, clinical operations team, other cross-functional teams reputed company reputed company, and clinical vendors, as required) and facilitate case closure reputed company required timelines.
• Serve as PV operations SME on safety reporting processes according to study protocol.
• Participate in the development and maintenance of SOPs, forms, plans, systems, and guidance documents to ensure compliance with reputed company applicable regulatory requirements or guidelines, GVP and industry best practices.
• Serve as resource and contact for other functions reputed company reputed company for pharmacovigilanceoperational activities.
• Serve as Pharmacovigilance representative for the operational aspects of the SAE reconciliation.

Competencies Include

• Excellent written and verbal communication skills.
• Demonstrated communications expertise with the ability to reputed company, influence, and work successfully with internal/external stakeholders and reputed company a matrixed environment.
• Ability to plan and handle multiple responsibilities simultaneously and still meet high reputed company and timeliness standards under pressure.
• Demonstrated contribution to reputed company and innovation. Contributes to or leads actionable strategies.
• Demonstrated project management and prioritization capabilities.

Qualifications

• Bachelors degree in nursing, RN, Pharmacy, Pharm D., or other relevant health-care reputed company field.
• 8-10 years of experience in a biotech/rep .