Drug Safety Physician

3 - 7 years

0 Lacs

Posted:1 month ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

As a Medical Reviewer in the Pharmacovigilance Department, you will be responsible for managing your daily workload under the guidance of the Manager. This includes individual case processing, conducting literature searches, generating aggregate reports, and completing any other tasks relevant to the department. Your role will involve medical review of Individual Case Safety Reports (ICSRs) in the Pharmacovigilance database, as well as preparing aggregate reports for expedited or periodic submissions in compliance with regulations and Standard Operating Procedures (SOPs). You will be expected to ensure compliance with the Company's SOPs and regulatory requirements, and provide support in signal detection of Adverse Drug Reactions (ADRs) for client products. Additionally, you may be involved in the medical review of Periodic Safety Update Reports (PSUR) and handling medical queries or spontaneous ADR cases as per applicable SOPs. Training and mentoring new medical reviewers in Pharmacovigilance may also be part of your responsibilities. Staying up-to-date with changes in regulations affecting pharmacovigilance activities and communicating these updates to relevant stakeholders is essential. You will be involved in the generation and execution of company SOPs and Work Instructions, and maintaining strong relationships with clients and internal/external contacts. Administrative duties, liaising with international offices and clients, and collaborating with cross-functional teams are also key aspects of this role. Your dedication to maintaining good relationships, following ISMS-related procedures and policies, and performing any other duties assigned by management will contribute to the overall success of the Pharmacovigilance Department. This is a full-time position that requires a Bachelor's degree. Kindly confirm if you hold an MBBS/MD qualification. Please note that the work location is in person, and you should be prepared to work collaboratively with team members to achieve required outcomes and meet timelines.,

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