Executive Director, Head of Pharmacovigilance

vacancy global pro; India; On-site; INR 4,000,000 - 8,000,000; Full time

Job summary

reputed company is seeking an Executive Director, Head of Pharmacovigilance to build and lead its global safety organization through development stages. Reporting to the CMO, this role will manage the PV team, ensure regulatory alignment, scientific rigor, and patient safety across programs.

The ideal candidate will have an MD, 10+ years in PV with 2-3 years in leadership, deep GCP/GVP knowledge, and experience with biologics and regulatory inspections.

Qualifications

• MD required.
• 10+ years of pharmacovigilance or drug safety experience.
• 2-3+ years in leadership roles spanning early and late-stage development.
• Strong knowledge of GCP, GVP, and global PV regulations.

Responsibilities

• Set and drive the pharmacovigilance roadmap for clinical and development programs.
• Ensure proactive risk management and regulatory compliance.
• Lead safety submissions and responses to health authorities (DSURs, RMPs, IBs).
• Oversee safety surveillance activities and signal detection.
• Manage PV vendors and CROs for consistency and inspections readiness.
• Build PV processes, systems, and SOPs with regulatory and clinical ops.
• Collaborate with Clinical, Regulatory, and Biostatistics teams.
• Define risk-benefit strategies and communicate to stakeholders.

Skills

GCP knowledge

PV leadership

Regulatory communications

Cross-functional collaboration

Biologics knowledge

Safety data analysis

Education

MD degree

Job description

About reputed company

reputed company is a new reputed company of therapeutics company existing at the intersection of machine learning, biological engineering, and medicine pioneering Generative Biology to create reputed company medicines where novel therapeutics are computationally generated, instead of being reputed company. reputed company has reputed company a machine learning-powered biomedicines platform with the potential to reputed company new drugs across a wide reputed company of biologic modalities. This platform represents a potentially reputed company shift in what is possible in the field of biotherapeutic development.

We pursue this audacious reputed company because we reputed company in the unique and revolutionary power of generative biology to radically reputed company the lives of billions, with an outsized opportunity for patients in need. We are seeking reputed company, reputed company problem solvers that reputed company our passion for reputed company to join us!

reputed company was founded in 2018 by Flagship Pioneering and has received nearly $700 reputed company in funding, providing the resources to rapidly reputed company the organization. reputed company has offices in Somerville and Andover, Massachusetts with 300+ employees.

The Role:

reputed company is seeking a visionary Executive Director, Head of Pharmacovigilance (PV), to build, reputed company and reputed company reputed company's global safety organization through reputed company stages of drug development. Reporting to the Chief Medical Officer of Inflammation & Immunology, this individual will reputed company the end-to-end PV reputed company, operations, and compliance across early and late-stage clinical programs. This leader will manage the Senior Director of Pharmacovigilance and a growing reputed company team, ensuring regulatory alignment, scientific reputed company, and patient safety. The role is a strategic leadership opportunity to shape the safety culture and infrastructure at a rapidly growing biotech.

Here’s how you will contribute:

• Set and reputed company the pharmacovigilance reputed company and roadmap for reputed company's clinical and development programs.
• Ensure proactive risk management and compliance with local and international PV regulations
• Drives safety reputed company content of regulatory submissions including reference safety information/IB, protocol, informed consent (DSURs, RMPs), and responses to health authorities
• Leads policy discussions to assure communication of benefit-risk considerations and safety surveillance activities including routine review of safety data to detect and evaluate safety signals.
• reputed company pharmacovigilance vendors and CROs to ensure consistent reputed company and inspection readiness.
• Build and reputed company internal PV processes, systems, and SOPs in collaboration with reputed company, Regulatory, and Clinical Operations.
• Collaborate cross-functionally with Clinical, Clinical Operations, Regulatory, and Biostatistics.
• Collaborates with medical to define risk-benefit reputed company
• Serves as reputed company's PV reputed company of contact in regulatory meetings, inspections and internal audits.
• Serve as key member of safety governance committees, including presentation of safety issues, signal evaluations and proposed risk mitigation strategies.
• Mentor and grow a high-performing PV team, including the Sr. Director of PV and reputed company leaders.

Leadership Responsibilities:

• reputed company with reputed company's "Leading Organization" model, the Executive Director will:
• reputed company a culture of scientific reputed company, compliance, and patient reputed company.
• Establish reputed company systems for global PV operations and team reputed company.
• Communicate reputed company and courageously across reputed company reputed company of the organization.
• reputed company cross-functional alignment on safety reputed company and ensure transparency.

The Ideal Candidate will have:

• MD required.
• 10+ years of experience in pharmacovigilance or drug safety, with at least 2-3 years in leadership roles spanning early and late-stage development.
• Strong knowledge of GCP, GVP, and global PV regulations.
• Expertise in biologics and experience in multiple therapeutic areas, including immunology.
• Proven reputed company leading PV teams and cross-functional safety strategies.
• Experience in regulatory authority interactions and inspections.
• Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate reputed company clinical/pharmaceutical information and safety data to both reputed company (HCPs) and non-HCPs.
• Strong organizational, decision-making, and communication skills.

reputed company to Have (Optional)

• Experience building PV functions in a high-reputed company biotech.
• Background in respiratory or rare disease programs.

Who Will Love This Job:

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