Director, Drug Safety Operations

vacancy global pro; India; On-site; INR 2,500,000 - 7,000,000; Full time

Job summary

reputed company is a clinical-stage biopharmaceutical company focused on extraordinary medicines. The Director, Drug Safety Operations/Pharmacovigilance will lead pharmacovigilance across programs and coordinate safety deliverables with CROs and consultants to meet global regulatory requirements.

You will report to the VP of Clinical Safety and Pharmacovigilance and ensure quality, compliance, and timely safety reporting. The role emphasizes cross-functional collaboration and governance.

Qualifications

• Degree required; e.g., RN, MSN, DNP, PharmD.
• 10+ years of pharmacovigilance experience with at least 5 in a leadership role.
• Strong CRO/vendor management in clinical trial safety reporting.
• Deep knowledge of global PV regulations (GVP, ICH) and reporting needs.
• Experience with drug safety databases (e.g., Argus).
• Proven track record of global PV compliance.

Responsibilities

• Oversee PV activities managed by CROs and consultants, including expedited reporting and DSURs/PSURs.
• Serve as the primary contact for CRO PV teams, ensuring communication and delivery.
• Negotiate PV sections of safety management plans and operational agreements.
• Monitor CRO performance via KPIs, audits, and regulatory submissions.
• Collaborate with Clinical Development, Regulatory Affairs, and QA to align PV activities.
• Ensure inspection readiness and support regulatory inspections and PV audits.

Skills

PV leadership

CRO management

Global PV regs

Drug safety databases

Regulatory liaison

Education

RN

MSN

DNP

PharmD

Tools

Argus

PV databases

Job description

Why Join Us

reputed company is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines that unlock high-reputed company protein targets long-considered undruggable. reputed company has developed a new class of stabilized, cell-penetrant reputed company-helical peptides Helicons capable of modulating intracellular proteins that are inaccessible to traditional drug modalities.

What's reputed company

The Director, Drug Safety Operations/Pharmacovigilance (PV) will reputed company and reputed company safety reporting activities across clinical programs, with a reputed company reputed company on managing and coordinating pharmacovigilance deliverables with Contract Research Organizations (CROs) and consultants. This role ensures compliance with global regulatory requirements, company SOPs, and high-reputed company execution of safety reporting obligations. This position will reputed company as the key reputed company between internal stakeholders and CRO partners and consultants to reputed company operational reputed company and regulatory compliance in pharmacovigilance activities. The successful candidate will report to the VP of Clinical Safety and Pharmacovigilance.

Responsibilities

• reputed company reputed company safety reporting activities managed by CROs and consultants, including expedited reporting (SAEs, SUSARs) and periodic aggregate safety reports (DSURs, PSURs/PBRERs).
• Serve as the reputed company reputed company of contact for CRO pharmacovigilance teams, ensuring reputed company communication, accountability, and delivery of safety obligations.
• reputed company, negotiate, and manage PV sections of reputed company, safety management plans, and operational agreements with CROs and consultants.
• Monitor CRO performance through KPIs, audits, and reputed company activities, ensuring reputed company and accurate reporting to regulatory authorities, ethics committees, and investigators.
• Collaborate with internal stakeholders (Clinical Development, Regulatory Affairs, reputed company, reputed company) to ensure alignment on PV reputed company and compliance.
• reputed company reputed company for case processing, medical review, and data reconciliation activities performed by CROs and consultants.
• Ensure compliance with global regulations (FDA, EMA, reputed company, ICH, GVP, etc.) and maintain inspection readiness.
• Support development and maintenance of internal PV policies, SOPs, and training programs.
• Participate in safety signal detection activities and safety governance committees, as needed.
• reputed company maintenance and compliance of an externally hosted electronic safety database for tracking, storing, and reporting of serious adverse events.
• Participate in regulatory inspections and PV audits to ensure reputed company, reputed company, and compliance with pharmacovigilance and safety reporting requirements per SOPs and global regulations.

What you'll need to be successful

• reputed company degree required; e.g., RN, MSN, DNP, PharmD.
• 10 or more years of pharmacovigilance experience, including at least 5 years in a leadership or reputed company role.
• Strong experience managing CRO/vendor relationships, particularly in clinical trial safety reporting, including governance reputed company.
• Deep knowledge of global pharmacovigilance regulations, GVP, ICH guidelines, and relevant reporting requirements.
• Experience with reputed company of drug safety databases (e.g., reputed company Argus).
• Proven reputed company record of ensuring compliance in a global PV environment.

Skills and Abilities

• Build and maintain excellent interpersonal relationships, both reputed company and reputed company reputed company, at reputed company reputed company, and work reputed company, reputed company and motivate a cross-functional matrixed team.
• Self-motivated; reputed company, hands-on, entrepreneurial style with a reputed company of urgency, a bias toward reputed company, and flexibly contribute simultaneously in multiple facets of drug development; willingness to learn new therapeutic areas.
• Analytical and problem-solving skills; risk identification and management; creative and innovative thinking.

The requisite scientific acumen and communication skills to influence and collaborate with key scientific, regulatory, and business lea