Luminary Group is excited to announce an opportunity for a skilled Pharmacovigilance Specialist to join a top pharmaceutical company. This is a fantastic chance to contribute to patient safety by managing and reporting safety data and ensuring compliance with regulatory requirements.
Responsibilities:
- Monitor and analyze adverse events and safety data for various drug products.
- Conduct thorough case reviews, documentation, and safety assessments.
- Prepare and submit safety reports to health authorities in compliance with relevant regulations.
- Participate in safety signal management and contribute to risk management plans.
- Work collaboratively with internal teams to facilitate timely and accurate reporting of safety information.
- Stay informed on current Pharmacovigilance regulations and industry standards.
- Assist in the development and refinement of Pharmacovigilance processes.
- Engage in training and mentoring roles for junior staff members.
Requirements
- Bachelor's or higher degree in Pharmacy, Life Sciences, or a relevant field.
- At least 3 years of experience in Pharmacovigilance or related areas within the pharmaceutical industry.
- In-depth understanding of Pharmacovigilance regulations and guidelines.
- Experience with case processing, including data entry, coding, and writing comprehensive narratives.
- Proficient in using industry-standard Pharmacovigilance databases and tools.
- Meticulous attention to detail with a focus on data integrity.
- Strong analytical skills to evaluate safety data effectively.
- Excellent written and verbal communication skills.
- Ability to thrive in a fast-paced environment and manage multiple priorities.
- Willingness to work as part of a dynamic team while also demonstrating independence.
