ProductLife Group is a leading global consulting and services provider specializing in regulatory affairs, pharmacovigilance, and clinical development. With a strong focus on compliance and innovation, PLG helps pharmaceutical and life sciences companies navigate complex regulatory landscapes. This role offers the chance to work with a dynamic team and contribute to the safety and efficacy of healthcare products.
Job Title: Data Officer (Clinical Safety)
Location: India (Remote)
Job Type: Full-Time
Key Responsibilities of a Data Officer (Clinical Safety)
As a Data Officer (Clinical Safety) at ProductLife Group, you will play a critical role in ensuring the accuracy and compliance of clinical safety data. Your responsibilities will include:
Advertisement
- Processing Adverse Events (AEs) and Serious Adverse Events (SAEs):
- Manage the entry and processing of AEs, SAEs, and SUSARs (Suspected Unexpected Serious Adverse Reactions) in the safety database.
- Ensure timely communication with customers regarding safety data.
- Query Management:
- Prepare, send, and follow up on safety-related queries.
- Study Tracker Maintenance:
- Maintain and update study trackers and other relevant tools to ensure accurate tracking of safety data.
- Data Reconciliation:
- Reconcile clinical safety information with customers, CROs, and data management teams.
- Safety Reports Preparation and Submission:
- Assist in the preparation of aggregate periodic safety reports.
- Support the submission of expedited and periodic safety reports to regulatory authorities.
Education and Experience Requirements
To qualify for this role, you should have:
- A degree in Pharmacy (PharmD) or a related scientific field.
- Experience in Pharmacovigilance/Drug Safety Data Entry.
- Proficiency in safety databases like SafetyEasy.
- Knowledge of pharmacovigilance regulations (national and international) and pharmaceutical products.
- Specific training in Pharmacovigilance/Drug Safety.
Skills Required for Success
The ideal candidate will possess the following skills:
- Attention to Detail: Ensure accuracy in data entry and reporting.
- Organizational Skills: Manage multiple tasks and prioritize effectively.
- Critical Thinking: Analyze safety data and identify potential risks.
- Effective Communication: Collaborate with internal teams and external stakeholders.
- Time Management: Meet deadlines in a fast-paced environment.
- Team Spirit: Work collaboratively with cross-functional teams.
Why Join ProductLife Group?
- Remote Work Flexibility: Enjoy the convenience of working from anywhere in India.
- Career Growth: Be part of a global team and gain exposure to international regulatory standards.
- Impactful Work: Contribute to the safety and efficacy of life-saving pharmaceutical products.
- Supportive Environment: Work with a team that values collaboration and innovation.
