Clinical Safety Contractor

**NITZ Consulting private Limited Inc. (“NItz”) **is committed to providing quality service in the field of pharmacovigilance to clients. Our clients range from mid-size to small pharmaceutical companies located worldwide who are engaged in developing a proprietary pipeline of novel therapies for the treatment of solid tumors and hematological malignancies.

The **Clinical Safety Contractor **will provide high-level support to Client and function by leading assigned developmental products, managing individual case safety reports (ICSR), and authoring aggregate safety reports. Prior experience and broad knowledge of pharmacovigilance/clinical safety, evaluation, and risk management is required. Work location: Remote

**Responsibilities**:

- Maintain understanding and ensure compliance with CS&RM SOPs and WPs, GCP, ICH guidelines, and applicable guidance documents/regulations (e.g., US FDA CFR and EU GVP) during the management of safety data received from company-sponsored and external partner studies.
- Analyze aggregate safety data within a clinical program towards tracking and trending of risk assessments and additional mitigation measures.
- Track and identify potential safety signals and escalate to the medical review function.
- Gather and analyze safety data for escalation and possible presentation to the Executive Safety Advisory Committee
- Facilitate deliverables using strong project management/time management.
- Contribute to safety sections of investigator or regulator communications, Investigator brochure, and other reports.
- Participate in the set-up and maintenance of adverse event processes for global clinical trials.
- Perform Quality Review of the ICSRs, including reviewing data entered within the safety database against the source documents and ensuring a concise and medically relevant case narrative.
- Obtain clinically meaningful information from investigators to provide a robust safety assessment.
- Support the development of electronic case report forms, participate in the configuration of the clinical database for safety specifications, perform User Acceptance Testing, maintain documentation.
- Assist with periodic reconciliation of safety data between the department and other sources (i.e., recon between the safety and clinical databases)
- Act as a liaison internally and externally (e.g., Clinical Development, Regulatory Affairs, Biometrics, parent company, and business partners) to develop programs and processes.
- Support the development and maintenance of SOPs, WPs, and other applicable documentation.

**Qualifications**:

- Required: PharmD
- Clinical (patient care) experience is preferred.
- A minimum of 4 years’ experience in Clinical Drug Safety and/or Pharmacovigilance
- Ability to maintain an “inspection ready” environment.
- Ability to present, train, and/or explain processes to all levels of the organization.
- Demonstrated competency within a Safety Database such as Argus or ARISg
- Previous experience within an EDC system is desirable.
- Initiative, resourcefulness, accountability, and teamwork

Pay: The hourly rate range for this position is INR 2,00,000 per month.

**Job Types**: Temporary, Freelance
Contract length: 12 months

**Salary**: ₹150,000.00 - ₹200,000.00 per month

**Benefits**:

- Cell phone reimbursement
- Internet reimbursement
- Work from home

Schedule:

- Night shift
- US shift

Supplemental pay types:

- Overtime pay

Ability to commute/relocate:

- Hyderabad, Telangana: Reliably commute or planning to relocate before starting work (preferred)

**Education**:

- Master's (required)

**Experience**:

- total work: 4 years (required)

**Speak with the employer**
+91 8328127521