Pharmacovigilence / Clinical Research specialist
7 days ago
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
Nandini (HR)
Mail to-
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