About Immuneel

Immuneel Therapeutics Private Limited is a pioneering start-up company leading the charge in cell therapy and personalized immunotherapy for patients in India. For more details, please refer www.immuneel.com

We Pursue, with Purpose, to serve our Patients (3 Ps) by Connecting within, Collaborating globally and Creating (3 Cs) solutions. Our flexible, diverse, and vibrant team is bringing together best practices and innovations in the field of cell and gene therapy.

Working at Immuneel promises the excitement of an agile start-up on a critical mission. Proudly Indian in solutioning, yet global in outlook, we are keen to collaborate. We value diversity including in experience and perspectives. We value work-life balance and believe that having fun on the job is integral to achieving the right results. We pride ourselves on providing an open environment and our mission resonates with humanity everywhere. At Work, we are:

- Passionate in driving patient outcomes: We are passionately committed to doing the RIGHT thing to achieve the best outcomes for our patients through innovation, agility and performance orientation. We put the impact on the patient above all else.
- Responsible and accountable: We demonstrate ownership and accountability for our actions. We make timely and well-informed decisions, learning from our performance.
- Transparent, honest, and supportive in how we work together: We insist on integrity and respect for the individual. We demand excellence. Our performance management is focused on excellence through timely and constructive feed-forward.
- Inclusive and flexible: We are full of life and embrace all opportunities to collaborate and work together. We are excited about the collective knowledge and expertise that we share. “Being and thinking different” is valued.

Immuneel’s employees are integral to our quest to develop and deliver high quality engineered cell therapies in India. We believe that our culture provides an setting for employees to excel and find purpose. The strength of our team is every bit as important as our cutting-edge technology and we invest in clear compensation and comprehensive benefits for our employees. People for us, are not resources, but our capital.

If you are a talented professional, an out-of-box thinker with a zeal to help change, and passionate about healthcare, we invite you to join us and be a part of a historic initiative in India.

Interested to be a part of the next revolution in cancer treatment? Send your resume to [email protected]

1. Role Title:

Manager – Drug Safety Operations (Pharmacovigilance)

2. Department / Function:

Clinical Development & Operations

3. Reporting Structure:

- Reports to: Clinical Development & Operations
- Direct Reports: Individual Contributor

4. Role Summary:

The role reports to the Head – Clinical Development & Operations and works closely with the Medical Affairs, Clinical Operations, Regulatory Affairs, Quality, and other cross-functional teams. The role is responsible for the effective execution and oversight of pharmacovigilance and drug safety activities across clinical development and post-marketing settings.

5. Key Responsibilities:

Pharmacovigilance & Drug Safety Operations

- Manage day-to-day pharmacovigilance and drug safety activities across clinical development and post-marketing settings.
- Coordinate the collection, review, documentation, assessment, follow-up,



and reporting of adverse events, serious adverse events, and other safety information.
- Ensure timely and accurate processing and reporting of individual case safety reports (ICSRs), as applicable.

Safety Data Collection from Hospitals & Sites

- Establish and maintain effective processes for systematic collection of safety and relevant clinical outcome data from hospitals and healthcare institutions administering the organization's products.
- Coordinate with hospital teams, treating physicians, investigators and other healthcare professionals to ensure timely reporting of safety information.
- Develop and maintain mechanisms for ongoing follow-up of patients and collection of relevant safety and outcome information following product administration.
- Ensure timely identification and follow-up of missing, incomplete, inconsistent, or clinically important safety information.
- Coordinate reconciliation of safety information received from hospitals with internal safety databases, clinical databases, and other relevant data sources.

Post-Marketing Surveillance & Real-World Data Generation

- Support the planning and execution of post-marketing surveillance (PMS) studies, safety monitoring programs, and real-world evidence (RWE) related data generation initiatives.
- Coordinate with Medical Affairs, Clinical Operations, hospitals, investigators, external partners, and other stakeholders for execution of PMS and RWE activities.
- Support development of study protocols, safety monitoring plans, data-collection tools, analysis plans, and related documentation.

Vendor & External Stakeholder Management

- Manage day-to-day interactions with external pharmacovigilance service providers, CROs, consultants, investigators, hospitals, and other safety-related partners.
- Define and monitor agreed deliverables, timelines, quality expectations, and operational requirements.
- Monitor vendor performance and ensure compliance with agreed processes, quality standards, and timelines.

Regulatory Compliance & Inspection Readiness

- Ensure pharmacovigilance activities are conducted in accordance with applicable regulatory requirements, guidelines, internal SOPs, and quality standards.
- Monitor compliance with safety reporting timelines and regulatory commitments.
- Support preparation for pharmacovigilance audits, inspections, regulatory submissions, and responses to regulatory queries.
- Support investigation and resolution of compliance issues, deviations, and CAPAs related to pharmacovigilance activities.

Safety Data Quality & Integrity

- Ensure completeness, accuracy, consistency, traceability, and integrity of safety data throughout the pharmacovigilance lifecycle.
- Conduct appropriate quality checks of safety data, reports, and related documentation.
- Monitor key PV quality metrics and identify trends requiring corrective or preventive action.
- Identify opportunities to improve standardization, efficiency, automation, and quality of safety-data processes.

Scientific & Medical Writing

- Prepare, review,



and coordinate pharmacovigilance and safety-related documents, including safety summaries, aggregate reports, study reports, regulatory responses, and other scientific documents.
- Support preparation of PMS and RWE study reports, manuscripts, abstracts, posters, presentations, and other scientific communications.
- Ensure scientific and safety-related content is accurate, evidence-based, consistent, and appropriately documented.

Project Management

- Independently manage assigned pharmacovigilance, PMS, and RWE projects and deliverables.
- Develop project plans, timelines, milestones, and tracking mechanisms.
- Monitor progress, identify risks and dependencies, and ensure timely escalation and resolution of issues.

Cross-Functional Collaboration

- Work closely with Medical Affairs, Clinical Development & Operations, Regulatory Affairs, Quality, Data Management, and other relevant functions on safety-related activities.
- Provide pharmacovigilance input into clinical development, product launch, post-marketing, medical affairs, and product lifecycle activities.
- Participate in relevant cross-functional meetings and provide updates on safety deliverables, risks, issues, and performance.
- Ensure timely communication and escalation of clinically significant or potentially reportable safety information.

Operational & Administrative Responsibilities

- Maintain appropriate trackers, dashboards, reports, and documentation for PV, PMS, and safety activities.
- Prepare periodic operational and management reports on safety deliverables, data quality, compliance, and project status.
- Support planning and monitoring of resources, budgets, contracts, and external service requirements related to pharmacovigilance activities.
- Perform other operational responsibilities relevant to the organization's pharmacovigilance, clinical development, and post-marketing objectives.

6. Competencies Required:

- Good understanding of pharmacovigilance and drug safety principles, preferably including both clinical development and post-marketing safety.
- Knowledge of applicable pharmacovigilance regulations, guidelines, SOPs, and reporting requirements.
- Understanding of clinical studies, study protocols, post-marketing surveillance, and real-world data generation.

7. Qualifications and Experience:

1. Doctoral or postgraduate degree in pharmacology. A degree in management is desirable.
2. 5 to 8 years of relevant experience in pharmacovigilance, drug safety, clinical research/operations, medical affairs, post-marketing surveillance, or a related function, preferably within the pharmaceutical, biotechnology, cell & gene therapy, or advanced therapy medicinal products (ATMP) sector.
3. Experience working with hospitals, investigators, healthcare professionals, and external PV vendors, with demonstrated ability to establish and maintain effective safety-data collection processes.
4. Experience in cell and gene therapy, advanced therapy medicinal products, or other complex biologic products will be an advantage, particularly experience with product-specific safety monitoring and post-treatment long-term follow-up.

8. Working Conditions:

- Role Type: Full Time, Onsite
- Work Hours: General Shift
- Travel Requirements: Yes
- Base Location: Immuneel Therapeutics Private Limited, 8th Floor, Mazumdar Shaw Medical Center, Narayana Health City, Bommasandra Industrial Area, Bangalore - 560099

📌 Manager – Drug Safety Operations (Pharmacovigilance) (Bengaluru)
🏢 Immuneel Therapeutics
📍 Bengaluru