Medical Safety Associate

2 weeks ago

Visakhapatnam, India AMBITIOUS HERBS INDIA PRIVATE LIMITED Full time

**Responsibilities**
- Provide support according to the needs for delivery activities, co-authoring safety documents and assisting in providing safety input to regulatory and clinical documents, as well as ad hoc Health Authority queries.
- Archiving all safety documentation as per respective policies, guidance, and procedures. Updating the Medical Safety SharePoint, uploading of documents, tracking and planning list updates
- Verification and update of respective PS archiving system (incl. review, update, management); Monitoring of the compliance. Support in organizing response to queries from Countries and regions and other functions outside medical safety
- Support in developing, updating, and implementing global procedures to ensure compliance. Management and maintenance of relevant Global PS databases/sharepoint.
- Preparing metrics as required and agreed with the manager. Support the Group Head, Medical Safety Operations/Medical Safety Group Lead/ Associate director Global Risk Management/ Associate director Quantitative safety and MedDRA in day to day operations as per assigned responsibilities
- Support Literature review for PSUR inclusion and assessment of literature for signals. Reviewing HA assessment reports and engaging and supporting the appropriate safety leads to address the questions by the HA
- Support in preparation of responses to internal safety requests and contribute to responses to external safety queries

**Minimum requirements**
- Bachelor of Science in Pharmacy / Bachelor of Science in Nursing / PharmD / PhD or Life sciences graduate.
- Good communication skills, and the ability to operate effectively in an international environment
- Good understanding of Human physiology, pharmacology, clinical study objectives, and the drug development process

**Salary**: ₹25,000.00 - ₹35,000.00 per month

**Benefits**:

- Flexible schedule
- Health insurance
- Life insurance

Schedule:

- Day shift
- Flexible shift

Supplemental pay types:

- Commission pay
- Yearly bonus

Ability to commute/relocate:

- Visakhapatnam, Andhra Pradesh: Reliably commute or planning to relocate before starting work (required)

**Education**:

- Diploma (preferred)

**Experience**:

- total work: 1 year (preferred)
- Health insurance

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