Drug Safety Scientist, Global Pharmacovigilance
BengaluruFull-time3–6 yrsPosted 2 days ago
Mid-level pharma role at GE HealthCare in Bengaluru. Needs 3+ years and a BBA.
About the role
The role provides scientific support to Medical Directors for the assessment of safety data from clinical trials and post-marketing experience and supports the EU QPPV in maintaining inspection readiness.
What you'll do
- Performs safety signal detection and evaluation using safety data and analytical tools to identify and assess potential signals, authors safety review documentation
- Apply data analytics and visualization tools to create and interpret trending analyses, investigate significant changes in reporting patterns
- Authors, reviews, and coordinates high-quality safety content for clinical development and post-marketing regulatory documents, including clinical study protocols
- Gathers, analyzes, and evaluates relevant scientific and safety information to support the development and maintenance of reference safety information within Company…
- Collaborates with PV Scientists and Medical Directors to provide scientific and medical input to responses to safety-related questions from regulatory authorities
What you need
- Pharmacovigilance
- SOP writing
- Documentation
- Communication
- Clinical research