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Summary:
- Luminary Group is seeking a motivated and experienced Pharmacovigilance Expert/Associate to join our client, a large pharmaceutical company on a full-time remote basis.
- As a Pharmacovigilance Expert/Associate, you will play a vital role in ensuring the safety and efficacy of our client’s pharmaceutical products.
Responsibilities:
- Review and evaluate adverse event reports and other safety-related information for our client’s products.
- Perform case processing activities, including data entry, coding, narrative writing, and quality checks.
- Conduct signal detection activities and contribute to the preparation of signal evaluation reports.
- Collaborate with cross-functional teams to ensure timely and accurate reporting of adverse events to regulatory authorities.
- Assist in the development and implementation of Pharmacovigilance processes and procedures.
- Maintain knowledge of current regulatory requirements and guidelines related to Pharmacovigilance.
- Ensure compliance with company policies and standard operating procedures.
- Contribute to the continuous improvement of Pharmacovigilance activities and systems.
Requirements:
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field.
- Minimum of 2 years of experience in Pharmacovigilance or a similar role.
- Strong knowledge of Pharmacovigilance practices and regulations.
- Experience with case processing activities, including data entry, coding, and narrative writing.
- Proficiency in using Pharmacovigilance databases and safety reporting systems.
- Ability to work independently and prioritize tasks effectively.
- Excellent attention to detail and accuracy in data entry and documentation.
- Strong analytical and problem-solving skills.
- Good interpersonal and communication skills, with the ability to effectively collaborate with cross-functional teams.
- Flexibility to work remotely and adhere to different time zones, if required.
