Sitero Mysore Hiring Drug Safety/Sr. Drug Safety Associate

Sitero, an emerging leader in clinical services and software solutions for the life sciences industry, is looking for a skilled Drug Safety Associate to join their team in Mysore, Karnataka. This role is perfect for professionals with a degree in Life Science or Pharma and a minimum of three years of experience in drug safety or clinical research. Join Sitero and be a part of an innovative team focused on ensuring the safety of pharmaceutical drugs through rigorous assessment and reporting.

Job Title: Drug Safety Associate

Location: Mysore, Karnataka

Department: Drug Safety Services

Job Description

As a Drug Safety Associate at Sitero, you will be responsible for assessing the safety of pharmaceutical drugs during clinical trials and post-marketing. This includes evaluating adverse reactions, collaborating with safety teams, and reporting findings to regulatory bodies. Your role will ensure that drugs are safe for patients and comply with all regulatory standards.

Key Responsibilities

• Analyze and interpret safety data from various sources.
• Perform end-to-end case processing of Individual Case Safety Reports (ICSRs) to meet regulatory timelines.
• Evaluate spontaneously reported adverse events, including those from post-marketing surveillance.
• Identify and manage duplicate or invalid ICSRs.
• Process case data from clinical trials, literature, spontaneous reports, market research, social media, and solicited cases.
• Enter subject information into Electronic Data Capture (EDC) databases accurately.
• Conduct peer and quality reviews of case entries.
• Code events, drugs, procedures, indications, and laboratory tests using appropriate dictionaries (e.g., MedDRA, WHO-DD).
• Ensure timely and accurate submission of safety information in case narratives.
• Contribute to safety and pharmacovigilance training programs.
• Collaborate with Regulatory Affairs for proper reporting to agencies and the medical community.
• Serve as a subject matter expert for vendors providing drug safety and pharmacovigilance services.
• Train and mentor Pharmacovigilance associates.

Qualifications and Experience

Essential:

• Minimum of three years of experience in drug safety or clinical research.
• Degree in Life Science, Pharma, or a related field.

Preferred:

• Over two years of experience in drug safety.
• Familiarity with safety databases and scientific coding browsers like MedDRA and WHO-DD.
• In-depth knowledge of drug safety and pharmacovigilance regulations.
• Strong organizational and documentation skills.
• Good knowledge of US and EU drug safety regulations, CIOMS, and ICH guidelines.
• Experience in safety data collection and interpretation from clinical trials and other sources.
• Excellent verbal, written, and presentation skills.
• Ability to build collaborative relationships across disciplines.

Compensation and Benefits

Sitero offers a competitive compensation package, including a competitive salary, variable pay, paid time off, healthcare, and retirement benefits. This is a full-time, permanent position with standard hours of 40 hours per week, Monday to Friday, and a willingness to work shifts as needed.

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