Remote Pharmacovigilance Signal Detection Specialist

Placements24

Paarl

Hybrid

ZAR 700,000 - 1,100,000

Full time

8 days ago

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Benefits offered by this job

Health insurance
Dental insurance
Vision insurance
Retirement plan
Paid time off
Professional development opportunities
Fully remote work

Job summary

Placements24 is partnering with a globally recognized pharmaceutical company to recruit a Remote Pharmacovigilance Specialist focused on signal detection. You will monitor safety data from spontaneous reports, literature, and trials, and contribute to risk management activities from anywhere in the world.

The role emphasizes proactive signal assessment, data mining, and statistical analysis to inform benefit-risk profiles.

Qualifications

  • Bachelor's or Master's degree in Pharmacy, Life Sciences, Nursing, or a related healthcare field.
  • Minimum of 3-5 years of experience in pharmacovigilance, with a strong emphasis on signal detection and case processing.
  • In-depth knowledge of pharmacovigilance principles, adverse event reporting, and global regulatory requirements (e.g., FDA, EMA).
  • Proven experience with signal detection methodologies and statistical analysis of safety data.
  • Proficiency in using pharmacovigilance databases and safety reporting software.

Responsibilities

  • Proactively identify, assess, and investigate potential safety signals from all available data sources.
  • Utilize data mining techniques and statistical tools to analyze large datasets for emerging safety trends.
  • Conduct comprehensive benefit-risk assessments for assigned products.
  • Prepare detailed signal evaluation reports, including recommendations for further investigation or action.
  • Collaborate with internal teams (e.g., Medical Affairs, Regulatory Affairs, Clinical Development) and external stakeholders to manage safety issues.
  • Contribute to the preparation and submission of Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs).
  • Ensure compliance with global pharmacovigilance regulations and company policies.
  • Monitor scientific literature and regulatory intelligence for relevant safety information.
  • Participate in cross-functional safety meetings and contribute expert safety insights.
  • Maintain accurate and up-to-date records in the safety database.

Skills

Pharmacovigilance
Signal detection
Data analysis
Statistical analysis
Regulatory knowledge
Communication

Education

Bachelor's/Master's in Pharmacy/Life Sciences

Tools

Safety reporting software

Job description

Placements24 is partnering with a globally recognized pharmaceutical company to recruit a Remote Pharmacovigilance Specialist focused on signal detection. You will monitor safety data from spontaneous reports, literature, and trials, and contribute to risk management activities from anywhere in the world.

The role emphasizes proactive signal assessment, data mining, and statistical analysis to inform benefit-risk profiles.

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