Senior Pharmacovigilance Safety System Analyst (Maternity Cover)

Location: India

Kelly FSP, is seeking a Senior Pharmacovigilance (PV) Safety System Analyst for a maternity cover, on behalf of one of our top pharma clients. If you are passionate about ensuring the safety and efficacy of pharmaceutical products and thrive in a collaborative, fast-paced environment, we want to hear from you!

As a Senior PV Safety System Analyst, you will:

• Ensure project methodologies and delivery standards are followed for all PV Systems projects.
• Partnering with Global Medical Safety (GMS) units and external partners, you will act as a process expert to improve compliance, quality, and efficiency.
• Elicit and document requirements, manage process and system changes, and create User Requirements Documents.
• Develop and execute UAT scripts, ensuring resource availability and correct documentation.
• 
  Lead the implementation of new PV systems and major upgrades, manage CAPAs, participate in audits and inspections, and handle change processes.
• Maintain controlled documents and training materials, providing training to subject matter experts.
• Oversight of the off-shore GMS Support Desk and ensuring adherence to SOPs and SLAs is critical. You will manage strategic partner resources and stay updated on industry and regulatory knowledge.

Requirements:

• BA/BSc degree in a health-related field or other scientific degree with 6+ years of experience or 8+ years of industry experience.
• Strong understanding of IT systems that support the entire PV process
• Experience in pharmaceutical safety, including individual and aggregate reports, and regulatory compliance.
• Knowledge of Quality Assurance for regulated computerized systems (FDA 21CFR part 11, GXP, EU directives & guidelines required)
• Strong analytical, organizational, and process skills with the ability to interpret business needs and translate them into requirements.
• Proficiency in MS Office tools, excellent documentation, verbal and written skills.
• Ability to manage multiple work streams, lead change, and thrive in a global matrix environment.

Preferred:

• Experience managing strategic partner resources for PV System-related activities.
• Knowledge of social media, digital marketing, and employee branding.

Join us and be part of a team making a global impact!