CNX Therapeutics is seeking an Executive, Pharmacovigilance & Medical Information for its Quality department. This opportunity focuses on pharmacovigilance operations, medical information management, regulatory compliance, vendor oversight, and audit readiness.
Candidates with experience in pharmacovigilance operations, PV/MI vendor and partner management, and knowledge of EU/UK Good Pharmacovigilance Practices (GVP) and ICH requirements can explore this opportunity. The position is listed for Mumbai, Maharashtra, with a fully remote work arrangement.
Job Details
| Particulars | Details |
|---|---|
| Company | CNX Therapeutics |
| Job Title | Executive, Pharmacovigilance & Medical Information |
| Department | Quality |
| Job Location | Mumbai, Maharashtra |
| Work Mode | Fully Remote |
| Job Type | Executive-level position |
| Qualification | Healthcare-related or Life Sciences education, or equivalent demonstrated experience |
| Experience | Experience in pharmacovigilance operations is essential |
Position: Executive, Pharmacovigilance & Medical Information
The selected candidate will support pharmacovigilance and medical information activities to ensure compliance with applicable regulations, company procedures, and industry standards.
The role involves overseeing vendor processing of adverse events and product complaints, supporting safety data reconciliation, coordinating medical information responses, maintaining controlled documentation, and contributing to quality and compliance initiatives.
Key Responsibilities
1. Pharmacovigilance Operations
- Support the day-to-day operation of the pharmacovigilance system.
- Oversee vendor processing of adverse events, special situation reports, and product complaints.
- Maintain accurate, complete, and inspection-ready pharmacovigilance documentation.
- Monitor pharmacovigilance email inboxes and ensure timely escalation and processing of safety information.
- Support safety data reconciliation with internal departments and external partners.
- Contribute to pharmacovigilance system master file reviews.
- Support due diligence and integration activities related to mergers and acquisitions.
2. Medical Information
- Support responses to medical information enquiries from healthcare professionals, patients, distributors, and other stakeholders.
- Collaborate with vendors to develop standard response documents.
- Ensure medical and scientific information is accurate, balanced, evidence-based, and timely.
3. Compliance and Quality
- Ensure activities comply with applicable regulations, GVP requirements, company procedures, and quality standards.
- Maintain procedures, work instructions, forms, and controlled documentation.
- Participate in Corrective and Preventive Action (CAPA), deviation, and change control activities.
- Contribute to continuous improvement initiatives.
4. Vendor and Partner Management
- Support pharmacovigilance agreements and partner compliance activities.
- Monitor the compliance of vendors and service providers involved in pharmacovigilance and medical information.
5. Audit, Inspection, and Training
- Support inspection readiness and maintain accessible records.
- Assist with internal audits, partner audits, and regulatory inspections.
- Prepare, collate, and review audit and inspection documentation.
- Maintain current knowledge of pharmacovigilance regulations and industry best practices.
- Support pharmacovigilance awareness training as required.
Eligibility and Qualifications
Candidates should meet the following essential criteria:
- Education in a healthcare-related or life sciences field, or equivalent demonstrated experience.
- Experience in pharmacovigilance operations.
- Demonstrated capability in pharmacovigilance and medical information vendor and partner management.
- Knowledge of EU/UK GVP and ICH requirements.
- Ability to translate regulatory requirements into compliant pharmacovigilance and medical information processes.
- Understanding of vendor oversight and audit readiness.
Required Skills
- Pharmacovigilance operations and safety information processing.
- Medical information enquiry management.
- PV/MI vendor and partner oversight.
- Regulatory compliance and quality management.
- Safety data reconciliation and documentation control.
- Audit and inspection readiness.
- CAPA, deviation, and change control support.
- Strong teamwork and communication skills.
- Cross-functional collaboration and proactive process improvement.
- Attention to detail and commitment to patient safety.
Salary and Benefits
CNX Therapeutics offers a competitive salary and benefits package aligned with local practices and statutory requirements. Details are shared during the recruitment process.
Application Details
