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Title
Text copied to clipboard!Drug Safety Specialist
Description
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We are looking for a Drug Safety Specialist to join our team and play a critical role in ensuring the safety and efficacy of pharmaceutical products. As a Drug Safety Specialist, you will be responsible for monitoring, evaluating, and reporting adverse drug reactions and other safety-related information throughout the product lifecycle. You will collaborate with cross-functional teams, including clinical research, regulatory affairs, and medical affairs, to ensure compliance with global pharmacovigilance regulations and company policies. Your expertise will help protect patient safety, support regulatory submissions, and contribute to the continuous improvement of our drug safety processes. Key responsibilities include collecting and analyzing safety data, preparing and submitting safety reports to regulatory authorities, conducting risk assessments, and participating in safety review meetings. You will also be involved in developing and maintaining standard operating procedures (SOPs) related to drug safety, training staff on pharmacovigilance requirements, and staying up-to-date with the latest regulatory guidelines and industry best practices. The ideal candidate will have a strong background in life sciences, excellent analytical and communication skills, and a keen attention to detail. Experience with pharmacovigilance databases, case processing, and regulatory reporting is highly desirable. This role offers an opportunity to make a meaningful impact on patient health and safety while working in a dynamic and collaborative environment.
Responsibilities
Text copied to clipboard!- Monitor and evaluate adverse drug reactions and safety data.
- Collect, process, and report safety information in compliance with regulations.
- Prepare and submit safety reports to regulatory authorities.
- Conduct risk assessments and safety signal detection.
- Collaborate with cross-functional teams on safety-related matters.
- Maintain and update pharmacovigilance databases.
- Develop and revise standard operating procedures (SOPs) for drug safety.
- Participate in safety review meetings and audits.
- Train staff on pharmacovigilance processes and requirements.
- Stay current with regulatory guidelines and industry best practices.
Requirements
Text copied to clipboard!- Bachelor’s degree in life sciences, pharmacy, nursing, or related field.
- Experience in pharmacovigilance or drug safety preferred.
- Familiarity with regulatory requirements (e.g., FDA, EMA, ICH).
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication skills.
- Attention to detail and accuracy in data handling.
- Ability to work independently and as part of a team.
- Proficiency with safety databases and reporting systems.
- Strong organizational and time management skills.
- Commitment to patient safety and ethical standards.
Potential interview questions
Text copied to clipboard!- What experience do you have in pharmacovigilance or drug safety?
- How do you ensure accuracy when processing safety data?
- Describe your familiarity with regulatory reporting requirements.
- Can you provide an example of a challenging safety case you managed?
- How do you stay updated on changes in drug safety regulations?
- What safety databases or systems have you used?
- How do you handle tight deadlines and multiple priorities?
- Describe your experience with cross-functional collaboration.
- What motivates you to work in drug safety?
- How would you train new staff on pharmacovigilance processes?
