Drug Safety Associate

6 days ago

Ahmedabad Gujarat, India Vertex Business Solutions Full time

**Job Summary**:
As a Drug Safety Associate, you will play a crucial role in ensuring the safety and well-being of patients by monitoring and reporting adverse events associated with our products. You will collaborate with cross-functional teams, including Clinical Development, Regulatory Affairs, and Medical Affairs, to assess and manage safety information throughout the product life cycle.

**Key Responsibilities**:

- **Adverse Event Management**:

- Receive and review adverse event reports from various sources, including healthcare professionals, consumers, and clinical trials.
- Ensure timely and accurate data entry of adverse event information into safety databases.
- **Case Processing**:

- Perform comprehensive evaluation of individual case safety reports (ICSRs) to determine seriousness, expectedness, and causality.
- Collaborate with medical professionals to gather additional information and clarify details related to adverse events.
- **Regulatory Reporting**:

- Prepare and submit expedited and periodic safety reports to regulatory authorities in compliance with local and international regulations.
- Keep abreast of regulatory requirements and communicate changes to the team.
- **Signal Detection and Risk Management**:

- Participate in signal detection activities and contribute to the development of risk management plans.
- Collaborate with cross-functional teams to assess and mitigate potential risks associated with product use.

**Communication**:

- Provide timely updates on safety issues to internal stakeholders and external partners.
- Assist in the preparation of safety sections for regulatory documents and responses to health authority inquiries.

**Qualifications**:

- Bachelor's degree in life sciences or related field; advanced degree (MSc, PharmD) is a plus.
- Previous experience in pharmacovigilance or drug safety is preferred.

**Job Types**: Full-time, Permanent, Fresher

**Salary**: ₹15,588.34 - ₹35,584.55 per month

**Benefits**:

- Cell phone reimbursement
- Health insurance
- Paid sick time

Schedule:

- Day shift
- Monday to Friday
- Morning shift

Supplemental pay types:

- Performance bonus

Work Location: In person

**Speak with the employer**

+91 7385069412

  • Drug Safety Associate

    2 days ago

    Ahmedabad, Gujarat, India Statistical Pharma Full time

    **Roles & Responsibilities of Drug Safety Physician** A Drug Safety Physician or Medical Reviewer is a medical professional who is responsible for evaluating and assessing the safety and efficacy of drugs, both before and after they are approved for use by the general public. They are typically recruited by the pharmaceutical companies, contract research...

  • Physician Associate

    1 week ago

    Ahmedabad, Gujarat, India RHEUMACARE Full time

    Company Overview Founded in 2014 as Dr. Shenoy's CARE, RheumaCARE has grown to become the largest standalone Rheumatology Centre in India. As we embark on a new journey, rebranding to RheumaCARE, we are committed to expanding our reach and bringing world-class rheumatologic care across the nation. Currently operating in 6 cities, we aim to grow to...

  • Drug Formulation Specialist

    2 weeks ago

    Ahmedabad, Gujarat, India beBeeResearch Full time ₹ 9,00,000 - ₹ 12,00,000

    About the JobWe are seeking a highly skilled and experienced individual to join our team as a Research Assistant.The successful candidate will be responsible for leveraging their expertise in formulation development and regulatory compliance to create stable and bioequivalent solid oral dosage forms for global markets.Key Responsibilities:Develop and...

  • Safety Assistant

    1 week ago

    Ahmedabad, Gujarat, India Advanced Clinical Full time US$ 40,000 - US$ 80,000 per year

    Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation. Based on decades of...

  • Safety Supervisor

    7 days ago

    Ahmedabad, India HPC Engineering Co. Full time

    **Responsibilities**: - Compile safety programs. - Practice safe working techniques. - Implement and maintain health and safety standards. - Establish a cordial and professional relationship with employees. - Maintain compliance with all safety regulations. - Conduct regular staff meetings to share best practice techniques. - Standardize health and safety...

  • Lead Drug-Device Combination Product Development

    2 weeks ago

    Ahmedabad, Gujarat, India beBeeMedicalDevice Full time ₹ 2,00,00,000 - ₹ 2,50,00,000

    Job Title: Senior Manager for Device Development">The Senior Manager / Deputy General Manager will be responsible for overseeing the development of complex drug-device combination products, including auto-injectors, pen injectors, and inhalers.">Key Responsibilities:">">Provide strategic direction and governance for device development projects, ensuring...

  • Leading Medical Safety Specialist

    2 weeks ago

    Ahmedabad, Gujarat, India beBeePharmacovigilance Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

    Job Title:Medical Safety SpecialistLead a team of medical professionals in ensuring the safety and efficacy of medications.Key Responsibilities:Develop and implement medical review plans to ensure compliance with regulatory requirements.Review adverse event reports and provide feedback on causality assessments.Collaborate with clients to understand their...

  • Subject Matter Expert

    1 week ago

    Gujarat, India Aditya Birla Group Full time

    **Designation**:Assistant General Manager **Updated**:February 25, 2025 **Location**:Gujarat, India **Organization**:Chemicals **JOB TITLE** **SAFETY - SUBJECT MATTER EXPERT** **REPORTS TO** **PROJECT HEAD - DOMESTIC CHLOR ALKALI BUSINESS** **FUNCTION** **SAFETY** **JOB PROFILE** Designing of Safety Policy & associated practices for ensuring that...

  • Safety Officer

    4 days ago

    Rajkot, Gujarat, India Varun Casting Co Full time

    A Safety Officer in a foundry business plays a crucial role in ensuring a safe working environment. Here are some key responsibilities: 1. **Compliance with Regulations** - Ensure adherence to local, state, and federal safety regulations. - Maintain updated knowledge of relevant safety laws and standards. 2. **Risk Assessment** - Conduct regular safety...

  • Safety Officer

    2 days ago

    Rajkot, Gujarat, India Varun Casting Co Full time

    A Safety Officer in a foundry business plays a crucial role in ensuring a safe working environment. Here are some key responsibilities: 1. **Compliance with Regulations** - Ensure adherence to local, state, and federal safety regulations. - Maintain updated knowledge of relevant safety laws and standards. 2. **Risk Assessment** - Conduct regular safety...