At Parexel, we share the goal of improving global health. From clinical trials to regulatory, consulting, and market access, our clinical development solutions are driven by a deep conviction in our mission. Each role at Parexel contributes to the development of therapies that ultimately benefit patients, making our work personal, empathetic, and committed to making a difference.
Vacancy Details :
- Position Name : Drug Safety Associate I
- Organization : Parexel
- Qualification: BDS, M.Pharm
- Experience: 0 YEARS / Freshers – 2 Year
- Salary: ₹4.9 Lakhs per year
- Location: Chandigarh, India (Office Based)
Description :
Adverse Event Reporting:
- Collected, processed, and evaluated adverse event reports from various sources, including healthcare professionals, patients, and clinical trials.
- Ensured timely and accurate reporting of adverse events to regulatory authorities in compliance with local and international regulations (e.g., FDA, EMA).
Case Management:
- Conducted thorough case assessments, including narrative writing and medical review, to determine causality and severity of adverse events.
- Maintained and updated pharmacovigilance databases with accurate case information and ensured completeness of data entries.
Signal Detection and Risk Management:
- Participated in signal detection activities to identify potential safety concerns and trends from collected data.
- Assisted in the development and implementation of risk management plans (RMPs) to mitigate identified risks associated with medicinal products.
Regulatory Compliance:
- Ensured compliance with Good Pharmacovigilance Practices (GVP), standard operating procedures (SOPs), and regulatory guidelines.
- Prepared and submitted periodic safety update reports (PSURs) and other regulatory documents to authorities as required.
Cross-functional Collaboration:
- Collaborated with clinical teams, regulatory affairs, quality assurance, and other departments to ensure integrated safety surveillance.
- Supported safety data exchange agreements (SDEAs) and contributed to the preparation of safety-related sections of regulatory submissions.
How To Apply :
CLICK HERE TO APPLY NOW :-Parexel Careers (myworkdaysite.com)
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