Pharmacovigilance Reporting Associate

This is a fully remote position, open to applicants in India.

📋 Description

• Prepare and evaluate safety reports, which encompass periodic safety updates and individual case safety reports.

• Gather and assess adverse event data from clinical trials as well as post-marketing sources.

• Keep abreast of current regulatory requirements and industry best practices pertaining to pharmacovigilance reporting.

• Work collaboratively with clinical, regulatory, and data management teams to obtain necessary information and address reporting challenges.

• Ensure prompt submission of safety reports to regulatory bodies and sponsors.

⛳️ Requirements

• A Bachelor's degree in life sciences, pharmacy, or a related discipline.

• Experience in pharmacovigilance or drug safety, with a solid grasp of safety reporting processes and regulatory standards.

• Exceptional attention to detail and organizational abilities, coupled with the capacity to accurately prepare and review complex safety reports.

• Strong communication and collaborative skills, with a proven track record of effective teamwork in a multidisciplinary environment.

• Capability to handle multiple tasks and prioritize efficiently in a fast-paced, regulated setting.

• Willingness to travel as needed (approximately 10%).

• Legal authorization to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Learning and development opportunities through structured training and career pathways.