Sitero Mysore Hiring Drug Safety/Sr. Drug Safety Associate

Sitero hiring Drug Safety Associate in Mysore. Life Science/Pharma graduates with 1+ year pharmacovigilance experience eligible.

Sitero is hiring a Drug Safety Associate (DSA) for its Drug Safety Services team based in Mysore, Karnataka. This role is ideal for life sciences and pharmacy professionals with hands-on experience in pharmacovigilance or clinical research who want to work on end-to-end safety case processing and global regulatory reporting. The position offers exposure to clinical trials and post-marketing safety data within a technology-driven, ethics-focused organization supporting global life sciences clients.

Company Overview

Sitero is an emerging leader in clinical services and software solutions for the life sciences industry. The organization provides technology-enabled services across early phase studies through Phase III clinical trials, helping sponsors and CRO partners maintain patient safety, regulatory compliance, and operational efficiency.

With a strong focus on ethics, innovation, and compliance, Sitero delivers high-touch drug safety and pharmacovigilance services that support regulatory reporting and risk management across global markets. The company’s collaborative culture and emphasis on continuous learning make it a strong workplace for professionals building long-term careers in pharmacovigilance.

Job Role & Responsibilities

The Drug Safety Associate is responsible for end-to-end pharmacovigilance activities, including safety data review, case processing, and regulatory reporting across clinical and post-marketing environments.

Drug Safety Associate (DSA)

Key Responsibilities

• Analyze, review, and interpret safety data from clinical trials, non-clinical studies, literature, and other relevant sources
• Perform end-to-end case processing of Individual Case Safety Reports (ICSRs) within regulatory timelines
• Conduct initial evaluation of spontaneously reported adverse events, including post-marketing surveillance reports
• Identify duplicate and invalid ICSRs and ensure accurate case reconciliation
• Process safety cases from clinical trials, literature, spontaneous reports, market research, social media, and solicited sources
• Perform accurate data entry of subject and case information into EDC and safety databases
• Conduct peer review and quality review of safety cases and EDC data as required
• Raise and track medical queries to ensure clarity and completeness of safety information
• Perform accurate medical coding using MedDRA, WHO Drug Dictionary, and company product dictionaries
• Develop clear, compliant case narratives reflecting appropriate safety information
• Ensure timely and quality submission of safety cases as per service level agreements
• Support pharmacovigilance training programs and continuous improvement initiatives
• Collaborate with Regulatory Affairs teams for timely submission of safety data to health authorities
• Act as a subject matter expert for vendors supporting drug safety activities
• Support training and mentoring of Pharmacovigilance Associates

These responsibilities directly contribute to patient safety, regulatory compliance, and ethical conduct of clinical research.

Eligibility / Qualifications

Educational Requirements

• Degree in Life Sciences, Pharmacy, or equivalent disciplines

Relevant Courses (comma-separated): B.Pharmacy, M.Pharmacy, Pharm.D, B.Sc Life Sciences, M.Sc Life Sciences, Clinical Research

Experience Requirements

• Minimum 1+ year of experience in drug safety or clinical research domain
• Hands-on exposure to pharmacovigilance case processing preferred

Preferred Skills & Knowledge

• Working knowledge of safety databases and coding dictionaries such as MedDRA and WHO-DD
• Strong understanding of pharmacovigilance regulations and practices
• Knowledge of US and EU drug safety regulations, CIOMS, and ICH guidelines
• Experience with safety data from clinical trials, literature, solicited, and post-marketing sources
• Strong documentation, organizational, and interpersonal skills
• Ability to collaborate effectively with cross-functional and external stakeholders
• Excellent verbal and written communication skills
• Proactive, innovative, and quality-focused mindset

Location & Salary

• Job Location: Mysore, Karnataka
• Employment Type: Full-time, Permanent
• Salary: Competitive with variable pay and benefits, aligned with industry standards

Compensation & Benefits

• Competitive fixed and variable pay structure
• Paid time off
• Healthcare and retirement benefits

Work Schedule & Commitments

• Standard working hours: 40 hours per week, Monday to Friday
• Willingness to work in shifts as required

Application Process

Interested candidates can apply through Sitero’s official hiring channels. Candidates are advised to submit accurate and complete information during the application process.

Frequently Asked Questions

Who can apply for this Drug Safety Associate role?

Candidates with life sciences or pharmacy qualifications and at least 1 year of drug safety or clinical research experience can apply.

Is this a clinical trial–only role?

No. The role involves safety data from clinical trials, literature, and post-marketing sources.

Where is the job located?

The position is based in Mysore, Karnataka.

Is shift work required?

Yes. Willingness to work in shifts is required as per project needs.

Is this a permanent role?

Yes. This is a full-time, permanent position.

Additional SEO Title Options

• Sitero Hiring Drug Safety Associate – Pharmacovigilance Jobs Mysore
• Drug Safety & Pharmacovigilance Careers at Sitero
• Sitero Clinical Research Safety Jobs – Drug Safety Associate

Summary Table

Company	Sitero
Vacancies	Drug Safety Associate
Required Education	Life Sciences, Pharmacy
Experience	Minimum 1+ Year

Tagged as: Pharma Jobs in Hyderabad