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About Company

Soterius Life Sciences Pvt. Ltd. is a subsidiary of Soterius Inc., headquartered in New Jersey, USA. Soterius is a uniquely positioned outsourced service provider with a team of experienced professionals from the pharma industry. They design customized, innovative, and cost-efficient processes for clinical safety, pharmacovigilance, and medical affairs. Soterius' clients include some of the top 10 global biopharmaceutical companies, and the company is known for its excellent quality, intelligence in products and solutions, and flexible approach to business.

Position Name :

Drug Safety Associate

Organization :

Soterius

Qualification:

B.Pharm /M.Pharm /BDS

Experience:

2 to 4 years

Salary:

₹ 8 Lacs per Year

Location:

New Delhi, Delhi, India (On-site)

  • Record and review adverse reactions in the safety database for post-marketing and clinical trial reports in accordance with regulatory standards.
  • Assess and review literature abstracts and full-text articles.
  • Communicate with required stakeholders as necessary.
  • Perform necessary administrative duties.
  • Support effective functioning of pharmacovigilance (PV) projects, including but not limited to case processing, literature monitoring, aggregate reporting, medical writing, signal detection and management, medical information, and risk management.
  • Ensure adherence to timelines and quality for assigned projects and tasks.
  • Manage quality, compliance, and documentation across PV projects.
  • Work with internal and external stakeholders to ensure compliance with agreements and applicable regulations.
  • Train and mentor personnel as needed.
  • Represent the department during audits and inspections.
  • Author and review SOPs and other relevant documents.
  • Perform other responsibilities as assigned by management.

Qualifications:

  • Education: B.Pharm/M.Pharm/BDS or equivalent qualification from a reputed institute recognized by the Pharmacy Council of India.
  • Experience: 2-4 years of experience in drug safety/pharmacovigilance.
  • Skills: Pharmacovigilance, regulatory affairs, and other relevant skills.

Application Link