Wanted Regulatory Affairs Specialist

4 days ago

Bengaluru Hosur Krishnagiri, India Resolve Full time ₹ 6,00,000 - ₹ 12,00,000 per year

Clinical trials is a crucial field in the pharmaceutical industry focused on drug safety. Professionals in this area monitor, assess, and prevent adverse drug reactions to protect public health.

Qualification & Specifications :

MBBS,BDS,BHMS,BAMS,BSMS,PHARMACYB.Sc/M.Sc (Life Sciences / Biology / Bio Chemistry / Micro Biology / Nursing / Bio Technology), B.P.T, B.E BIOMEDIAL, B.Tech (Biotechnology/Bio Chemistry).

passed out

Skills Required:

  • Scientific Background: Degree in Pharmacy, Life Sciences, or Medicine.
  • Attention to Detail: Meticulous accuracy in data entry and documentation.
  • Analytical Skills: Ability to analyze data and identify safety signals.
  • Regulatory Knowledge: Understanding of Good Pharmacovigilance Practices (GVP) and other regulations.

Key Responsibilities:

  • Case Processing: Receive, document, and process reports of adverse drug reactions (ADRs) from various sources, ensuring accurate data entry into safety databases.
  • Signal Detection: Analyze safety data to identify new risks or trends associated with a drug.
  • Risk Management: Develop and implement strategies to mitigate identified risks, ensuring the drug's benefits outweigh its potential harms.
  • Regulatory Reporting: Prepare and submit safety reports (e.g., PSURs) to regulatory authorities, ensuring compliance with global guidelines.
  • Documentation: Create and maintain accurate and compliant scientific and regulatory documents, including Standard Operating Procedures (SOPs) and safety reports.

For more details contact

Nithila (HR)

Mail to-

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