Drug Safety Associate

2 weeks ago


Pune, India Fusion Technology Solutions Full time

**Job Summary**

Responsible for providing medical and clinical insight and guidance through clinical trials for pharmaceuticals.

**Primary Responsibilities**
- 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.

**Salary**: ₹282,922.63 - ₹1,035,191.88 per year

**Benefits**:

- Health insurance

Schedule:

- Day shift
- Morning shift
- Rotational shift

Supplemental pay types:

- Joining bonus
- Performance bonus

Ability to commute/relocate:

- Pune, Maharashtra: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- total work: 1 year (preferred)

**Speak with the employer**
+91 9156086642



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