Executive, Pharmacovigilance & Medical Information

CNX Therapeutics Limited; Mumbai; On-site; INR 1,400,000 - 2,100,000; Full time

Job summary

CNX Therapeutics Limited in Mumbai is seeking an Executive, Pharmacovigilance and Medical Information to support PV and MI activities, ensuring regulatory compliance, quality standards, and patient safety across the organization.

You will collaborate with internal teams and external vendors to process safety data, respond to medical information requests, maintain ready documentation, and participate in audits and continuous improvement initiatives.

Qualifications

• Educated in a health care related or life science field or equivalent demonstrated experience is required
• Experience in pharmacovigilance operations is essential
• Demonstrated capabilities in PV/MI vendor and partner management
• Knowledge of EU/UK GVP, ICH requirements with the ability to operationalise legislation into compliant PV and MI processes, vendor oversight, and audit readiness
• Excellent teamwork and communication skills, with the ability to influence and partner effectively with cross-functional stakeholders

Responsibilities

• Support the day-to-day operation of the pharmacovigilance system in accordance with applicable regulations, guidelines, and company procedures.
• Oversee vendor processing of adverse events, special situation reports, and product complaints received from internal and external sources.
• Ensure pharmacovigilance documentation is maintained accurately, completely, and in an inspection-ready state.
• Monitor pharmacovigilance email inboxes and ensure timely escalation and processing of safety information.
• Support vendor and Line Manager with pharmacovigilance related activities as required.
• Assist with safety data reconciliation activities with internal departments and external partners.
• Support due diligence activities for potential future mergers and acquisitions.
• Support integration activities following mergers and acquisitions.
• Contribute to the review of the pharmacovigilance system master file.

Education

Healthcare or life sciences background

Job description

At CNX Therapeutics, we’re building a growing European pharmaceutical business with a clear ambition: to improve access to medicines that make a meaningful difference to patients’ lives. With a diverse portfolio and an expanding global footprint, we’re continuing to grow through both our existing business and new opportunities.

Our people are central to this journey. We’re a collaborative, entrepreneurial and fast-moving organisation where individuals have the opportunity to take ownership, make an impact and help shape how we grow. Joining CNX means becoming part of an ambitious team at an exciting stage of our development, with the opportunity to contribute to both our business and the patients we ultimately serve.

The Opportunity

The Executive, Pharmacovigilance and Medical Information will be responsible for supporting the management of pharmacovigilance and medical information activities to ensure compliance with applicable regulatory requirements, company procedures, and industry standards.

Working alongside the Senior Manager, Pharmacovigilance and Medical Information, you will be working closely with internal teams and external service providers with processing, assessment, and reporting of safety information, while also providing accurate, balanced, and timely medical information responses to healthcare professionals, patients, partners, and other stakeholders.

You will be organised, pay strong attention to detail and be a great communicator whilst ensuring patient safety remains the highest priority.

What You’ll Be Doing

Pharmacovigilance Operations

• Support the day-to-day operation of the pharmacovigilance system in accordance with applicable regulations, guidelines, and company procedures.
• Oversee vendor processing of adverse events, special situation reports, and product complaints received from internal and external sources.
• Ensure pharmacovigilance documentation is maintained accurately, completely, and in an inspection-ready state.
• Monitor pharmacovigilance email inboxes and ensure timely escalation and processing of safety information.
• Support vendor and Line Manager with pharmacovigilance related activities as required.
• Assist with safety data reconciliation activities with internal departments and external partners.
• Support due diligence activities for potential future mergers and acquisitions.
• Support integration activities following mergers and acquisitions.
• Contribute to the review of the pharmacovigilance system master file.

Medical Information

• Support vendor with responses to medical information enquiries from healthcare professionals, patients, distributors, and other stakeholders in a professional and timely manner.
• Collaborate with the vendor to support the development of standard response documents as required.
• Ensure scientific and medical information provided to stakeholders is accurate, balanced, and evidence-based.

Compliance and Quality

• Ensure all pharmacovigilance and medical information activities are conducted in accordance with applicable regulations, GVP requirements, company procedures, and quality standards.
• Support the maintenance of pharmacovigilance and medical information procedures, work instructions, forms, and controlled documentation.
• Participate in CAPA, deviation, and change control activities as required.
• Contribute to quality and compliance initiatives to support continuous improvement.

Vendor and Partner Management

• Support pharmacovigilance agreements and partner compliance activities.
• Support compliance monitoring of vendors and service providers involved in pharmacovigilance and medical information activities.

Audit and Inspection Readiness

• Support inspection readiness activities, ensuring records and documentation are maintained and accessible.
• Assist with internal audits, partner audits, and regulatory inspections.
• Participate in the preparation, collation, and review of audit and inspection documentation.

Training and Development

• Maintain current knowledge of pharmacovigilance regulations, medical information requirements, and industry best practices.
• Support the delivery of pharmacovigilance awareness training as required.

What We’re Looking For

Essential

• Educated in a health care related or life science field or equivalent demonstrated experience is required
• Experience in pharmacovigilance operations is essential
• Demonstrated capabilities in PV/MI vendor and partner management
• Knowledge of EU/UK GVP, ICH requirements with the ability to operationalise legislation into compliant PV and MI processes, vendor oversight, and audit readiness
• Excellent teamwork and communication skills, with the ability to influence and partner effectively with cross-functional stakeholders

You’ll also bring

• A commitment to quality and compliance: you care about standards and process integrity
• A proactive approach to improvement: you look for ways to make systems and processes work better
• A collaborative style: you communicate clearly and help promote a culture of quality across the business

What We Offer

We offer a competitive salary and benefits package in line with local practice and statutory requirements. Full details will be shared during the recruitment process.