At a Glance
- Tasks: Monitor product safety and report adverse events while collaborating with global teams.
- Company: Globally recognized biopharmaceutical company focused on patient safety.
- Benefits: Competitive remote salary, health insurance, retirement plan, and flexible paid time off.
- Other info: Join a dedicated team with ongoing support for professional development.
- Why this job: Make a real impact on patient safety from the comfort of your home.
- Qualifications: Degree in healthcare and 6+ years in pharmacovigilance or drug safety.
The predicted salary is between 98550 - 120450 $ per year.
About the Role
Our client, a globally recognized biopharmaceutical company, is seeking a highly experienced Remote Senior Pharmacovigilance Officer .
This critical role ensures the continuous monitoring of product safety and the reporting of adverse events in compliance with global regulatory standards.
You will play a key role in safety data analysis, signal detection, and the development of risk management strategies.
As a fully remote position, exceptional organizational skills, proactive communication, and the ability to work autonomously are essential.
You will collaborate closely with internal and external stakeholders across different time zones, contributing to the safety of patients worldwide.
This is a fantastic opportunity to advance your career in pharmacovigilance from the convenience of your home office.
Key Responsibilities
- Oversee the collection, processing, and reporting of adverse event data from various sources (clinical trials, post-marketing, literature).
- Conduct medical and scientific review of adverse event reports, including causality and seriousness assessments.
- Participate in the detection and assessment of safety signals, contributing to risk management strategies.
- Prepare and review periodic safety update reports (PSURs/PBRERs) and other regulatory safety documents.
- Ensure compliance with global pharmacovigilance regulations (e. g., FDA, EMA, ICH guidelines) and company SOPs.
- Liaise with regulatory authorities and external partners on safety-related matters.
- Collaborate with cross-functional teams, including clinical operations, medical affairs, and regulatory affairs, on safety surveillance activities.
- Contribute to the development and implementation of pharmacovigilance quality management systems.
- Provide training and guidance to other pharmacovigilance team members.
- Contribute to the development and review of safety sections of clinical study protocols, investigator brochures, and informed consent forms.
Requirements
Degree in Pharmacy, Medicine, Nursing, Life Sciences, or a related healthcare field.
A minimum of 6 years of experience in pharmacovigilance or drug safety within the pharmaceutical or biotechnology industry.
In-depth knowledge of global pharmacovigilance regulations, guidelines, and reporting requirements.
Proven experience in adverse event case processing, medical assessment, and signal detection.
Strong analytical, critical thinking, and problem-solving skills.
Excellent written and verbal communication skills, with the ability to articulate complex safety information clearly and concisely.
Demonstrated ability to work independently and manage multiple tasks effectively in a remote work environment.
Proficiency in safety databases and standard office software.
Experience working with global teams across different time zones is highly desirable.
Benefits
Our client offers a highly competitive remote salary, comprehensive health, dental, and vision insurance, a generous retirement savings plan with company match, and flexible paid time off.
We provide a robust virtual onboarding process and ongoing support for professional development, including access to online training, webinars, and relevant scientific conferences.
This fully remote position offers unparalleled flexibility and the opportunity to make a significant impact on patient safety from anywhere, working with a dedicated and collaborative global team.
You will be part of an innovative company committed to developing life-changing therapies.
#J-18808-Ljbffr
Senior Pharmacovigilance Officer – Remote in Kimberley employer: Placements24
Join a forward-thinking company that values innovation and offers a fully remote work environment, allowing you to thrive from anywhere in South Africa. With a highly competitive salary, significant bonus potential, and a generous budget for professional development, this role as Legal Counsel - Intellectual Property not only provides the opportunity to protect and manage a diverse IP portfolio but also fosters a culture of growth and collaboration. Embrace the chance to work on cutting-edge technology while shaping the future of the company's intellectual property.
