Assistant Manager/Deputy Manager - Clinical Safety and Pharmacovigilance

SOTERIUS LIFE SCIENCES INDIA; Oregon; Hybrid; USD 120,000 - 160,000; Full time

Job summary

Soterius, Inc. seeks an experienced Assistant Manager/Deputy Manager for Clinical Safety and Pharmacovigilance. The role focuses on leading PV activities, mentoring staff, and ensuring regulatory compliance in a remote, full-time capacity. 6–8 years of PV experience preferred.

The candidate will manage risk management plans, conduct medical reviews, and drive QA and audits while coordinating with cross-functional teams to maintain high safety data standards.

Qualifications

• Pharmacovigilance experience required in global regulatory environments.
• Experience in training and mentoring team members.
• Strong communication and coordination skills.
• Ability to manage multiple priorities independently.

Responsibilities

• Support development and review of Risk Management Plans (RMPs) and risk minimisation measures.
• Perform medical and scientific review of safety data and signals.
• Ensure compliant safety data management, reporting, and QA.
• Support safety listings, aggregate reporting and signal detection.
• Ensure regulatory compliance and timely delivery of PV activities.
• Manage stakeholder communications, deliverables and escalations.
• Support audits, inspections and quality improvement initiatives.
• Assess system upgrades impact on PV workflows.
• Train and mentor team members to ensure quality and compliance.
• Author and review SOPs and controlled documents.
• Support audit preparation and responses.

Skills

Pharmacovigilance

Team management

Mentoring

Communication

Time management

Regulatory knowledge

Education

B.Pharm

M.Pharm

BDS

Job description

Assistant Manager/Deputy Manager - Clinical Safety and Pharmacovigilance

6-8 years

Remote

Full-Time

Job Description – Assistant Manager/Deputy Manager - Clinical Safety & Pharmacovigilance

Key Responsibilities

• Support the development, review, and implementation of Risk Management Plans (RMPs) and additional risk minimisation measures, including effectiveness assessments.
• Perform medical and scientific review of safety data, including individual case reports, aggregate reports, and signal management activities.
• Ensure accurate and compliant safety data management, reporting, documentation, and quality review.
• Support safety listings, aggregate reporting, and signal detection activities.
• Ensure regulatory compliance, project quality, and timely delivery of assigned PV activities.
• Manage stakeholder communications, project deliverables, and operational escalations.
• Support audits, inspections, and continuous process improvement initiatives.

Technology Solutions Support

• Assess the impact of system upgrades and enhancements on aggregate reporting, signal detection, and PV workflows.
• Collaborate with technology teams to identify, test, and implement system improvements.
• Train, mentor, and support team members to ensure quality and compliance.
• Identify training needs and support team development and operational management.
• Ensure team readiness for audits, inspections, and quality reviews.

Quality & Compliance

• Author and review SOPs, work instructions, and controlled documents.
• Support audit preparation, coordination, and responses.
• Ensure compliance with applicable regulatory requirements, client procedures, and internal quality standards.
• Undertake additional responsibilities as assigned by management.

Required Skills & Experience

• More than 6 years of pharmacovigilance experience.
• Experience in team management, training, and mentoring.
• Strong knowledge of global pharmacovigilance regulations and regulatory requirements.
• Ability to work independently and manage multiple priorities.
• Excellent communication, coordination, and time management skills.

Educational Requirements

• Graduate/Postgraduate qualification in a relevant scientific or healthcare discipline, such as B.Pharm, M.Pharm, or BDS, or equivalent.