Pharmacovigilance Associate
3 weeks ago
Provide medical and clinical guidance to managers before, throughout, and following clinical trials.
- Maintain consistency of safety assessments.
- Perform a variety of safety assessments.
- Serve in cross-functional teams as a medical and scientific representative.
- Ensure regulatory compliance and safety throughout trial.
- Submit periodic reports to the Food and Drug Administration.
- Ensure that medical and causality assessments of all clinical and post-marketing adverse event fillings to foreign regulatory authorities are consistent with company policies, as well as the respective foreign regulatory requirements.
- Address labeling concerns and updates.
- Interpret regulatory mandates.
- Assist with internal and external drug safety audits
- Create company data sheets.
- Remediate any pharmacovigilance deficiencies found during regulatory or internal audits.
- Act as medical expert during product development.
- Establish and maintain consistency of safety assessments within the US and outside the US.
- Identify the correct actions and facilitate, support and implement them as appropriate.
- Review performance metric data and clarify inconsistencies and trends.
Pay: ₹9,297.72 - ₹29,837.72 per month
**Benefits**:
- Internet reimbursement
Schedule:
- Day shift
Supplemental pay types:
- Performance bonus
Ability to commute/relocate:
- Pune, Maharashtra: Reliably commute or planning to relocate before starting work (required)
**Experience**:
- total work: 1 year (preferred)
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