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Drug Safety Physician

Job Description - 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


- Good communication
skills


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About the Company

Apcer Life Sciences India

APCER Life Sciences brings together safety, medical, regulatory & technology services to ensure that patients receive the safest therapies possible.

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