Safety submissions specialist
The Safety Submission Specialist will be responsible for reviewing and transmitting individual case safety reports to global regulatory agencies and business partners. The role involves managing safety databases, performing reconciliation, and ensuring compliance with global drug regulations. Candidates must have clinical trial safety experience and proficiency with reporting portals like EudraVigilance and Argus. This position is essential for supporting drug development safety compliance.
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Experience
2+ years
Function
Healthcare Services
Work mode
Onsite, India
Company
Tier 2
What you will work on
The Safety Submission Specialist will be responsible for reviewing and transmitting individual case safety reports to global regulatory agencies and business partners. The role involves managing safety databases, performing reconciliation, and ensuring compliance with global drug regulations. Candidates must have clinical trial safety experience and proficiency with reporting portals like EudraVigilance and Argus. This position is essential for supporting drug development safety compliance.
TAL's take
Solid role within a defined clinical research domain, clear requirements, but standard industry-specific administrative focus.
The JD provides a highly specific list of regulatory compliance and reporting tasks consistent with drug safety roles.
Must haves
- Knowledge of global safety reporting regulations and guidelines
- Knowledge of the ARGUS Safety Database
- Minimum 2 years experience in clinical trial drug safety in Pharma/CRO
- Experience with EMA EudraVigilance, UK MHRA and reporting portals
Tools and skills
About the company
Established clinical research organization providing services in the pharmaceutical and biotech sector.
Posts mentioning Precision For Medicine
Gala Precision IPO Risks
- **Gala Precision Engineering**'s IPO started on September 2 and ends on September 4, with a price range of ₹503-529 per share. - The **Red Herring Prospectus (RHP)** lists 10 key risks investors should know before investing. - Loss of key customers or reduced demand could adversely affect **Gala Precision Engineering**'s business and financial condition. - The company lacks long-term contracts with suppliers, risking increased costs or quality issues. - **Gala Precision Engineering** is dependent on a few application industries; downturns could impact its financial health.
I wish startups give this as a joining bonus
Maybe if it were released in 2021…
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