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About the Role
The Pharmacovigilance (PV) Associate Scientist conducts PV-related work in compliance with ICH-GCP, SOPs, project-specific procedures, and applicable regulatory requirements.
Responsibilities
- Manage project-specific activities including preparation/review of safety management plans, data management plans, case report forms, safety databases (Veeva Vault Safety, ArisG, Argus, cubeSAFETY), configuration documents, and project kick-off meeting slides.
- Provide study-specific safety reporting training to investigators/study teams and manage end-to-end PV projects.
- Perform case processing activities, draft safety narratives, monitor safety mailboxes, and file study documents in the Trial Master File (TMF).
- Manage site and regulatory submissions for expedited and periodic reports (line listings and DSUR).
- Serve as a key contact or point of expertise for team members and external contacts for designated projects/processes.
- Participate in safety reconciliation activities as requested by the client.
- Liaise with medical monitors/Pharmacovigilance physicians, clients, and study teams to clarify information.
- Participate in inspection/audit activities and assist in the preparation or implementation of corrective/preventative actions related to case processing.
- Ensure timely submission of reports to regulatory agencies in accordance with regulations and track submission details for compliance.
- Undertake any other responsibilities assigned by the line manager.
Requirements
- Registered nurse, pharmacist, or holder of a health/biomedical or related scientific degree/qualification.
- 2 to 4 years of pharmaceutical/CRO experience with a focus on safety-related areas in clinical trials.
- Knowledge/experience in international drug safety-regulatory reporting obligations and compliance.
- Strong computer proficiency and ability to work in specific databases.
- Ability to follow guidelines and procedural documents.
- Fluent in both written and oral English.
- Good interpersonal skills for professional communication at all organizational levels.
- Good time management and multi-tasking capabilities.
Skills
- Veeva Vault Safety
- ArisG
- Argus
- cubeSAFETY
- MedDRA coding
- WHO-DD coding
- Case processing
- Safety report submission
Location
- Remote
- Hybrid
Work Type
- Hybrid
- Full-time
Experience Level
- 2-4 years
Education Level
- Registered nurse/pharmacist or health/biomedical degree or related scientific degree/qualification
- Postgraduate qualifications or certification in clinical trials (advantageous)
Benefits
- Hybrid working arrangements
- Full flexibility in working hours
- Paid parental leave for both parents
- Flexible leave entitlements
- Wellness programs
- Ongoing development programs
- NovoLife flexible benefits framework
About the Company
- Novotech is a global full-service clinical Contract Research Organization (CRO).
- Novotech is a globally recognized leader in clinical research and scientific advisory services.
- Novotech has an award-winning workplace culture that values ambition, innovation, and growth.
- Novotech has been named Employer of Choice, Great Place to Work, and Employer of Choice for Gender Equality (EOCGE).
- Novotech fosters an environment that reflects the life-changing work they do.
- Since 1997, Novotech has expanded its global footprint with over 30 offices across Asia-Pacific, the United States, and Europe.
- Novotech unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide.
- Novotech offers trust, flexibility, and autonomy through programs like NovoLife to empower team members to create an effective work-life balance.
- Novotech provides access to mentorship opportunities, professional development programs, and a dynamic community.
- Novotech has advanced therapeutic and regulatory expertise, the ability to execute across markets, and a client-centric service model.
- Novotech offers employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture.
- Novotech employees work with clients on the cutting-edge of life sciences.
- Novotech teams have a shared commitment to success, a strategic vs. transactional mindset, and the ability to gain insights and make proactive decisions quickly.
- Novotech fosters a culture that promotes partnership and collaboration, where every voice is heard and valued, with ongoing support from senior stakeholders and the leadership team.
Equal Opportunity
- Novotech is committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.
- Novotech is looking for people who are passionate about working in clinical research and biotech, including people who identify as LGBTIQ+, have a disability, or have caring responsibilities.
- Novotech is a Circle Back Initiative Employer and commits to respond to every application.