Title: Drug Safety Associate/ Senior Drug Safety Associate/ Team Lead (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:
- Record and review adverse reactions in the safety database for post marketing and clinical trial reports in accordance with applicable regulatory standards, with high accuracy and quality.
- Assessment and review of literature abstracts and full-text articles.
- Communicate with required stakeholders, as necessary, to carry out the operational responsibilities.
- Carry out necessary administrative duties required for the job.
- Support effective functioning of PV projects (including but not limited to case processing, Literature Monitoring, Aggregate Reporting, Medical Writing, Signal Detection and Management, Medical Information and Risk Management etc.) in compliance with 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.
- Continuously work with internal and external stakeholders to ensure compliance with agreements, applicable regulation and guidance’s.
- Train and mentor personnel, as needed.
- Respond to/ represent department/ function during audits and inspections.
- Author and review SOPs and other documents relevant for department/ function.
- Other responsibilities as assigned by the Management.
Education & Experience:
- B.Pharm / M.Pharm / BDS or equivalent qualification from a reputed institute recognized by Pharmacy Council of India
- 0-8 years of experience in drug safety / pharmacovigilance
