Remote Pharmacovigilance Specialist

Placements24; Kimberley; Hybrid; CAD 75,000 - 110,000; Full time

Benefits offered by this job

Remote work flexibility

Competitive salary

Health & retirement benefits

Job summary

Placements24 is seeking a Remote Pharmacovigilance Specialist to join the safety surveillance team. The role involves collecting, assessing, and reporting adverse events for products globally while supporting PSUR/PBRER documentation.

Remote work offers flexibility and demands strong regulatory and safety database proficiency. The candidate should have a Bachelor's degree in a healthcare field and at least 3 years in pharmacovigilance, with experience in Argus/ArisG and global regulatory

Qualifications

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
• 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, ArisG) and adverse event reporting systems.

Responsibilities

• Collect, process, and assess adverse event reports from various sources (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.

Skills

Pharmacovigilance

Safety databases

Medical terminology

Education

Bachelor in Pharmacy or Life Sciences

Tools

Argus

ArisG

Job description

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, ArisG) 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.