Drug Safety and Pharmacovigilance - Assistant Manager/Team Leader

Title: Assistant Manager/Team Leader (exact title and level will depend on the candidate’s profile and experience)

Role Type: Full-time

Location: On-site from our office in Delhi

Company: Soterius Life Sciences Pvt. Ltd. is a subsidiary of Soterius Inc. which is a uniquely positioned outsourced service provider headquartered in New Jersey, USA (www.soterius.com). We are a strong team of experienced professionals from the pharma industry who design customized, innovative, and cost-efficient processes for clinical safety, pharmacovigilance, and medical affairs. Our deep industry knowledge and up-to-date insights let us combine agile, people-powered intelligence with big data in pioneering customer-centric solutions. Our clients include some of the Top 10 global biopharmaceutical companies, who love our work and our solutions. Customers constantly appreciate our focus on excellent quality, intelligence in our products and solutions, and our flexible approach to business.

Soterius Life Sciences India Pvt. Ltd. is looking for energetic and enthusiastic life sciences professionals who are passionate about patient safety to work as Safety Associates for a fast-paced, customer-focused service provider.

Key Responsibilities:

• Ensures effective functioning of PV projects in compliance with client agreements and applicable regulations and guidelines.
• Have ownership of assigned projects and tasks and ensure adherence to timelines and quality.
• Management of quality, compliance, and documentation across PV projects
• Manage and monitor workload of department function and alert the functional head / designate in the event of concerns or issues regarding personnel management that may affect the quality and functioning of the work.
• Continuously work with internal and external stakeholders to ensure compliance with agreements, applicable regulation, and guidance’s.
• Author and review SOPs and other documents relevant for department/ function
• Other responsibilities as assigned by the Management.

Required Skills/Experience

• More than 4 years of experience in the CRO or pharmaceutical industry including more than 2.5 years of pharmacovigilance experience.
• Awareness of global regulatory and pharmacovigilance environment
• Experience in line management with excellent people and time management skills.