Drug Safety Physician

DUTIES & RESPONSIBILITIES

• Manage daily workload in conjugation with line manager for individual case processing, literature searches, aggregate reports generation and any other tasks relevant to the Pharmacovigilance Department.

• Medical Review of ICSR's in pharmacovigilance database and aggregate reports for expedited/periodic submission as per the Regulations and SOPs.

• Signal detection of the ADRs with cases received from client's products

• Medical Review of PSUR as per the Regulations and SOPs

• Handling of medical query/spontaneous ADR cases as per applicable SOP • Generation and review of SOPs and WIs and execution of company SOPs

• Maintain awareness of changes to/new regulations affecting PVG activities

• Compliance to project guidelines • Trains and mentors new employees in PVG (if required)

• To carry out necessary administrative duties required for the job

• Other duties as assigned by management • Builds and maintains good relationships across functional units and company affiliates

Requirements

REQUISITE EDUCATION LEVEL & EXPERIENCE

• A graduate/post-graduate degree in medical science.

• 0-2 yrs. relevant experience;

• Knowledge of regulatory requirements

• Good time management skills

• Good presentation skills

• Ability to plan & prioritise projects and work effectively

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• Good communication skills