Drug Safety Specialist
6 days ago
Job Title:
Medical Reviewer / Medical Quality Reviewer
Location:
Pune | NCR | Kolkata
Working Model:
Hybrid
Qualifications:
- MBBS (Medical Degree), preferably with a postgraduate qualification.
- Minimum
2+ years of experience
in clinical practice or pharmacovigilance (PV). - Must hold valid
Medical Doctor certification/licensure
in the country of service. - Experience in the pharmaceutical industry preferred.
- Working knowledge of
international regulations and guidance documents
related to worldwide reporting requirements (US/EU).
Key Responsibilities:
- Perform comprehensive
medical review
of cases, ensuring consistency and accuracy of information. - Provide
causality assessment
and
clinical evaluation comments
as required. - Support the preparation of
clinical trial safety assessments
,
regulatory submissions
, and
aggregate safety reports
. - Ensure compliance with
pharmacovigilance regulations
and company policies. - Identify and resolve issues independently; escalate complex matters appropriately.
- Demonstrate strong
analytical and decision-making skills
in both routine and complex scenarios. - Collaborate effectively within a
matrix organization
, working both independently and under supervision. - Maintain high productivity, organization, and time management to meet regulatory compliance goals.
- Exhibit
excellent oral and written communication
in English.
Skills & Competencies
- Strong understanding of
pharmacovigilance processes
and
safety data management
. - Proficiency in
database management systems
and computer applications. - Excellent organizational and problem-solving skills.
- Ability to work under tight timelines while maintaining quality standards.
-
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