Are you an experienced professional in pharmacovigilance and drug safety? Parexel, a globally recognized CRO (Contract Research Organization), is hiring for the position of Drug Safety Specialist in Mohali, India. This role is ideal for individuals with expertise in drug safety management, regulatory compliance, and medical monitoring activities. If you have a background in life sciences, pharmacovigilance, or biomedical sciences, this could be the perfect opportunity to advance your career.
Job Purpose
As a Drug Safety Specialist, you will be responsible for:
- Supporting clinical trial and post-marketed drug safety management
- Handling Individual Case Safety Reports (ICSRs) from various sources
- Conducting literature searches, signal detection, and management
- Performing regulatory submissions and assisting in the preparation of safety reports
- Ensuring compliance with global and local regulatory guidelines
- Managing medical and product dictionaries where applicable
Key Responsibilities
General Duties:
- Maintain knowledge of drug safety regulations, SOPs, and labeling documents.
- Ensure adherence to global pharmacovigilance reporting obligations.
- Participate in project-specific safety procedures and training sessions.
- Support audits and inspections by regulatory authorities.
- Work closely with clients and internal stakeholders to ensure high-quality deliverables.
- Mentor new team members when required.
Case Processing:
- Monitor and triage incoming safety reports from various sources (e.g., email, Eudravigilance, literature searches).
- Perform medical coherence and data consistency checks.
- Enter data into the safety database, ensuring accuracy and compliance with SOPs.
- Conduct MedDRA coding, causality assessment, and seriousness evaluation.
- Generate line listings and tabulations for safety reports.
- Ensure timely submission of safety reports to regulatory authorities and business partners.
Regulatory & Literature Review:
- Develop and maintain expedited reporting procedures.
- Register with regulatory authorities for electronic safety reporting.
- Track and file submission cases as per SOPs.
- Perform literature searches for safety signals, regulatory requests, and periodic safety reports.
- Maintain an updated database of local and international literature sources.
Required Skills & Qualifications
Skills:
- Strong knowledge of pharmacovigilance processes and drug development.
- Proficiency in global safety regulations and compliance requirements.
- Ability to perform data analysis and signal detection.
- Strong problem-solving, analytical, and communication skills.
- Experience in regulatory submission and case processing.
- Familiarity with MedDRA, WHO Drug Dictionary, and literature search tools.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Education & Experience:
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Microbiology, Biochemistry, Biotechnology, or related fields.
- Minimum of 2 years of experience in ICSR processing ✅ Expertise in global and local literature screening for drug safety ✅ Demonstrated proficiency in Pharmacovigilance processes ✅ Strong commitment to upholding drug safety standards..
