Medical Safety Expert, Sandoz

IN04 (FCRS = IN004) Sandoz Private Limited; Telangana; Presencial; INR 1.200.000 - 1.800.000; Jornada completa

Descripción de la vacante

Sandoz Private Limited is seeking a Drug Safety professional to oversee drug surveillance, including adverse reaction case processing, risk assessment, and safety input for regulatory and clinical documents.

The role involves coordinating safety activities across product life cycle, mentoring junior staff, and providing SME guidance within Medical Operations.

Formación

• Experience in clinical research, clinical trials and regulatory compliance.
• Strong literature review and medical records evaluation.
• Ability to manage safety deliverables and support Health Authority queries.
• Training and mentoring of junior team members.

Responsabilidades

• Co-author safety documents and provide safety input to regulatory/clinical documents.
• Monitor safety profile of products including literature reviews and case evaluations.
• Support safety input for regulatory submissions and new indications.
• Follow up on Health Authority assessment reports and queries.
• Lead training and mentoring of junior team members.
• Distribute marketing samples where applicable.

Conocimientos

Clinical Research

Clinical Trials

Regulatory Compliance

Safety Science

Literature Review

Medical Records

Process Safety

Functional Teams

English

Descripción del empleo

Job Description Summary

-Responsible for the drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs. Participates in the resolution of any legal liability and complying with governmental regulations. Provides and contributes trending and safety signal detection and risk management assessment for the products’ life cycle. Provides safety support to the clinical development teams.

Job Description Major accountabilities

Provides support according to the needs for delivery activities, i.e. co-authoring safety documents and assisting in providing safety input to regulatory and clinical documents, as well as ad hoc Health Authority queries. Assist in monitoring the safety profile of products including with activities such as literature review, medical review/evaluation of individual cases or signal detection. Perform literature review -Provide support for the preparation of ad hoc Health Authority queries for TAs, also in particular for short term notice requests. Perform follow up activities on Health Authority Assessment Reports. Assist in providing safety input to Regulatory Affairs and clinical documents. Support maintenance and management of local deviations -Assist in evaluating and writing other safety deliverables as assigned -Provide support as needed for new indication submission (regulatory document safety input). Prepare responses to internal safety requests and contribution to responses to external safety queries. Act as Subject Matter Expert (SME) for Medical Operations/ Medical Function -Lead the training and mentoring of junior team members/colleagues -Distribution of marketing samples (where applicable)

Key performance indicators

• Timeliness and quality of safety analyses, interpretations, and presentations
• Compliance with internal and external regulations and procedures
• Compliance, consistency and quality of safety deliverables

Minimum Requirements

Work Experience: People Challenges. Managing Crises. Functional Breadth. Collaborating across boundaries. Operations Management and Execution. Project Management. Skills: Clinical Research. Clinical Trials. Functional Teams. Literature Review. Medical Records. Process Safety. Regulatory Compliance. Safety Science. Languages : English. Skills Desired Clinical Research, Clinical Trials, Functional Teams, Literature Review, Medical Records, Process Safety, Regulatory Compliance, Safety Science

Our Purpose here at Sandoz

is pioneering access for patients. As the global leader in ‘off-patent’ high quality medicines, we are able to make medicine more affordable and accessible. Our broad global portfolio comprises of approximately 1,300 quality biosimilar and generic medicines, enabling us to provide more than 900 million patient treatments across 100+ countries per year, and while we are proud of this achievement, we have an ambition to do more! Powered by our talented and ambitious colleagues, who, in return for dedication and skills, experience a flexible, collaborative & inclusive culture where diversity of thought is welcomed and where personal growth is nurtured!