Associate Director, Pharmacovigilance Operations

remote next; India; On-site; INR 13,849,092 - 19,770,772; Full time

Job summary

Therapeutics is seeking Associate Director, PV Operations to lead key pharmacovigilance functions, including case management, data management collaboration, and global safety reporting. The role emphasizes regulatory compliance and cross-functional leadership across clinical development teams.

The candidate should have extensive PV regulatory knowledge, experience with safety data agreements, and a track record of managing vendor relationships and inspections. Oncology exposure is preferred.

Qualifications

• Experience in global program support; oncology experience preferred.
• Expertise in case management and global safety reporting compliance.
• Significant experience with Safety Data Exchange Agreements and partner management.
• Demonstrated competency in safety vendor and inspection readiness.
• Proven ability to manage safety data flows and ensure reporting compliance.
• Advanced knowledge of global PV regulations (US CFR, EU GVP, ICH).
• Proficiency with drug safety databases (Argus preferred).
• Excellent communication skills.
• Minimum of 6 years of relevant industry experience, including 4 years in drug safety.
• RN or PharmD degree preferred

Responsibilities

• Develop and lead PV operations functions including SAE processing and reporting.
• Maintain regulatory reporting calendars and global reporting matrices.
• Create and update study-specific safety management plans with study teams.
• Oversee SAE start-up activities and CRO case management including database maintenance.
• Coordinate submission and distribution of expedited safety reports to authorities, investigators, CROs, and partners.
• Collaborate with data management to annotate SAE eCRFs for sponsored studies.
• Oversee Safety Service Provider activities to SAE management and ICSR reporting.
• Maintain safety templates and forms with cross-functional stakeholders and CROs.
• Contribute to safety content in protocols, CRFs, CSRs and regulatory submissions.
• Ensure staff and external personnel are trained in pharmacovigilance principles and procedures.
• Manage the safety mailbox and key PV communications.

Skills

Global program support

Case management

Safety reporting compliance

Excellent communication

Vendor management

Education

RN or PharmD preferred

Tools

Argus

Safety databases

Job description

reputed company The Associate Director, PV Operations is responsible for developing and leading key PSRM operational functions, including case management reputed company and compliant global ICSR and aggregate safety reporting. This role is responsible for reputed company of safety operations activities including but not limited to collection, management and reporting of SAE and other safety information from clinical programs, maintenance and updates to safety database and ensuring compliance to Safety Data Agreements and global regulatory requirements. The position partners closely with clinical development and program teams to guide safety management throughout reputed companys portfolio.

Your Role

• reputed company and maintain departmental SOPs, work instructions, and guidelines reputed company to SAE processing and reporting.
• Maintain regulatory reporting calendars and global reporting requirement matrices.
• Create and update study-specific safety management plans in collaboration with study teams.
• reputed company SAE-reputed company study start-up activities and reputed company CRO case management operations, including database maintenance.
• reputed company reputed company submission and distribution of expedited safety reports to regulatory authorities, investigators, CROs, and partners.
• Collaborate with data management to reputed company SAE eCRFs for reputed company-sponsored studies.
• reputed company Safety Service Provider-executed safety operations activities reputed company to SAE management, ICSR reporting, and aggregate reporting.
• reputed company and maintain safety templates and forms with cross-functional stakeholders and CROs.
• Contribute to safety content in, protocols, CRFs, CSRs and regulatory submissions.
• Ensure internal personnel are trained in pharmacovigilance principles, policies/procedures and external personnel are trained in safety reporting requirements & procedures.
• Manage the reputed company safety mailbox.

Your Background

• Experience in global program support required; experience in oncology programs, is preferred.
• Expertise in case management reputed company and global safety reporting compliance.
• Significant experience with Safety Data Exchange Agreements/Pharmacovigilance Agreements and partner management.
• Demonstrated competency in safety vendor reputed company and inspection readiness.
• Proven ability to manage reputed company safety data flows and ensure reporting compliance.
• Advanced knowledge of global PV regulations, including US CFR, EU GVP, and ICH guidelines.
• Proficiency with drug safety databases, preferably Argus.
• Excellent communication skills.
• Minimum of 6 years of relevant industry experience, including 4 years in drug safety.
• reputed company degree RN or PharmD preferred

Estimated Salary

reputed company [$145,000 - $207,000]. The reputed company provided above is based on reputed company reputed company to be a reasonable estimate for this job at the time of posting. Actual reputed company salary will depend on a number of factors, including but not limited to, a candidates education, experience, skills and location.

#BP1 About reputed company

Therapeutics reputed company Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. reputed company on unparalleled insights into protein reputed company and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial reputed company on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates an reputed company of leading-edge experimental and computational approaches to reputed company a differentiated understanding of protein structure and reputed company to drug these targets. We have reputed company a world-class team of leading experts from reputed company of these disciplines, and they are driven by a deep collaboration at every reputed company of our drug discovery process. reputed company is reputed company reputed company and reputed company, with a shared passion for working collaboratively in intellectually stimulating environments.

If youre excited by the challenge of putting protein reputed company at the heart of drug discovery and passionate about making a difference in the lives of patients, join us!