At a Glance
- Tasks: Collect and assess adverse event data to ensure drug safety.
- Company: Global pharmaceutical leader focused on patient safety.
- Benefits: Competitive salary, health benefits, retirement contributions, and remote work flexibility.
- Other info: Join a collaborative team dedicated to continuous learning and work-life balance.
- Why this job: Make a real impact on public health while working from anywhere.
- Qualifications: Bachelor's degree in healthcare and 3 years of pharmacovigilance experience.
The predicted salary is between 81000 - 99000 $ per year.
About the Role
Our client, a global pharmaceutical leader, is seeking a dedicated and experienced Remote Pharmacovigilance Specialist to join their safety surveillance team.
This fully remote position plays a critical role in ensuring the safety of our client's marketed and investigational products.
You will be responsible for the collection, assessment, and reporting of adverse event data, as well as contributing to signal detection and risk management activities.
The ideal candidate possesses a strong understanding of pharmacovigilance principles, regulatory reporting requirements, and safety databases.
You will work in a collaborative environment, interacting with internal teams and external stakeholders to maintain the highest standards of patient safety.
This is an excellent opportunity to make a significant impact on public health while enjoying the flexibility of remote work.
We are looking for a meticulous and proactive individual passionate about drug safety and regulatory compliance, contributing to our operations across South Africa .
Key Responsibilities
- Collect, process, and assess adverse event reports from various sources (e. g., clinical trials, post-marketing).
- Ensure timely and accurate reporting of adverse events to regulatory authorities and other stakeholders.
- Maintain and utilize safety databases for tracking and managing adverse event information.
- Contribute to the preparation of periodic safety update reports (PSURs/PBRERs) and other safety documents.
- Participate in signal detection activities and risk management planning.
- Collaborate with medical, clinical, regulatory, and legal departments on safety-related issues.
- Ensure compliance with global pharmacovigilance regulations and company SOPs.
- Review relevant literature for safety information pertaining to company products.
- Respond to safety inquiries from internal and external parties.
- Contribute to the continuous improvement of pharmacovigilance processes and systems.
Requirements
- Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field. Advanced degree is a plus.
- Minimum of 3 years of experience in pharmacovigilance or drug safety.
- Thorough understanding of global pharmacovigilance regulations (e. g., FDA, EMA, ICH guidelines).
- Experience with safety databases (e. g., Argus, Aris G) and adverse event reporting systems.
- Strong medical terminology and case processing skills.
- Excellent analytical, organizational, and problem-solving abilities.
- Outstanding written and verbal communication skills, with the ability to articulate complex safety information.
- Proficiency in managing tasks and working independently in a remote setting.
- Detail-oriented with a commitment to patient safety and data integrity.
- Experience with signal detection methodologies is an advantage.
Benefits
- Our client offers a competitive salary, comprehensive health and wellness benefits, retirement fund contributions, and ample paid time off.
- This is a fully remote position, providing significant flexibility.
- You will have the chance to work on challenging and impactful projects, contributing to global drug safety initiatives, with our corporate presence in the vicinity of Kimberley .
- We foster a culture of collaboration, continuous learning, and work-life balance.
- This role is vital for ensuring the safety and well-being of patients worldwide.
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Pharmacovigilance Specialist – Remote in Kimberley employer: Placements24
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