Continuum India is a leading organization in the healthcare and pharmaceutical sector, specializing in pharmacovigilance and drug safety. With a commitment to maintaining the highest standards of compliance and delivering excellence, Continuum India empowers professionals to contribute to global healthcare solutions. Recognized for its employee-friendly policies and career growth opportunities, the company is a fantastic place for freshers to begin their journey in PV science.
Role Overview: Fresher Pharmacovigilance Scientist
Basic Function:
As a PV Scientist, you will process Individual Case Safety Reports (ICSRs), prepare aggregate safety reports, and manage activities related to signal detection and regulatory compliance for adverse events (AEs) and serious adverse events (SAEs).
Key Responsibilities
- ICSR Management:
- Process adverse events for both marketed and investigational products (human and veterinary).
- Perform follow-ups, analysis, and regulatory reporting in compliance with global regulations.
- Aggregate Report Preparation:
- Draft Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), and other scheduled or unscheduled reports.
- Conduct quality checks and ensure accuracy in aggregate data reporting.
- Signal Detection and Reporting:
- Analyze data for cumulative trends and issue-specific events.
- Generate signal evaluation reports to identify and mitigate risks.
- Regulatory Compliance:
- Maintain awareness of global regulatory obligations and adhere to timelines.
- Collaborate with internal and external stakeholders to resolve report discrepancies.
- Knowledge Maintenance:
- Stay updated on the safety profiles of assigned drugs, labeling documents, and regulatory guidelines.
Qualifications and Skills
Educational Background:
- Mandatory: Master’s degree in Life Sciences (e.g., Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics).
- Preferred: A degree in Dentistry or prior experience in pharmacovigilance.
Key Skills:
- Strong knowledge of medical terminology and regulatory requirements.
- Proficiency in MS Office Suite (Word, Excel, PowerPoint) and web-based applications.
- Excellent analytical and problem-solving skills.
- Ability to create concise, accurate summaries of medical texts and data.
- Attention to detail and a high level of flexibility in work prioritization.
- Fluency in written and spoken English.
