Assistant Manager/Deputy Manager - Clinical Safety and Pharmacovigilance
Company: Soterius
- Location: India
- Work mode: Remote
- Seniority: Senior
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
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.
People Leadership & Training
- 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.
