Beaver Life Science (BLS) is a leading research-driven service provider specializing in clinical development research services and public health research. With a strong focus on global business opportunities, BLS collaborates with academic institutions, hospitals, pharmaceutical companies, CROs, NGOs, and government agencies. The organization also offers industry-relevant practical training, internships, and professional certification programs tailored for pharma undergraduate and postgraduate students, emphasizing Clinical Research Organization (CRO) practices.
Located in Panvel, Maharashtra, BLS is committed to advancing clinical research and pharmacovigilance through quality, compliance, and innovation.
Job Title: Senior Executive – Clinical Research and Pharmacovigilance
Location: Moshi, Pune, Maharashtra
Experience Required: 2.5 to 3 years in CRO or Site Operations
Salary Range: ₹2.25 to ₹3 Lakhs per annum
Work Days: 6 days a week
Joining: Immediate joiners preferred
Job Description
Beaver Life Science is hiring a Senior Executive – Clinical Research and Pharmacovigilance to manage and execute clinical research projects and pharmacovigilance activities across various study types, including Drugs, Medical Devices, Ayurvedic, and Nutraceuticals. The role involves end-to-end project management from study initiation to close-out, ensuring regulatory compliance, quality assurance, and stakeholder coordination.
Key Responsibilities:
- Sponsor/CRO/Site Identification: Evaluate and onboard suitable sponsors, CROs, and investigator sites.
- Project Initiation & Start-Up: Lead project kick-off meetings, assign teams, and define deliverables and timelines.
- Study Start-Up: Prepare and submit study documents, obtain Ethics Committee (EC) and DCGI approvals.
- Study Conduct Management: Oversee site initiation, monitoring visits, data entry, SAE reporting, and patient advocacy.
- Study Close-Out: Manage site close-out, data reconciliation, document archiving, and final study reports.
- Clinical Documentation: Draft, review, and approve protocols, CRFs, ICFs, CSRs, and source documents.
- Safety Reporting: Process Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports.
- Patient Advocacy: Build patient databases, provide counseling, and facilitate clinical trial enrollment.
- Site Database Development: Maintain a robust site database through systematic evaluation.
- Quality Assurance & Audits: Conduct internal/external audits ensuring GCP and regulatory compliance.
- SOP Development: Develop and improve SOPs for Sponsor, CRO, and Site processes.
- Regulatory Intelligence: Track and communicate regulatory updates.
- Business Development: Support talent outsourcing services for clinical research and pharmacovigilance professionals.
- Academic Clinical Trials: Coordinate academic trials with medical and pharmacy institutions.
- Training & Development: Mentor interns and new employees; conduct ICH-GCP workshops.
- Regulatory Submissions: Facilitate Ethics Committee setups, CRO QMS systems, and regulatory registrations.
- Reporting & Monitoring: Maintain trend reports and monitor Clinical Trial Registries (CTRI).
Key Skills Required
- Strong technical knowledge of clinical study processes
- Excellent communication and interpersonal skills
- Ability to work independently and collaboratively in a team
- Experience in CRO or site operations
- Knowledge of regulatory guidelines and GCP compliance
How to Apply
Interested candidates with the required experience can submit their updated resumes/CVs to the following email address:
📧 Email: info@beaverlifescience.com
For more information, contact:
📞 +91 91758 69672 | +91 90193 56356
