This pharmaceutical company focuses on gastrointestinal, dermatologic, and women’s health therapeutics.
Title: Pharmacovigilance Specialist, Regulatory Affairs - JO#2206-5785
Therapeutic Area: Gastrointestinal
Territory: Connecticut, Massachusetts
The Pharmacovigilance Specialist participates in the monitoring and review of adverse events, medical information requests, and product complaints. This role reports to the Associate Director, Regulatory Affairs.
Essential Duties and Responsibilities
- Familiar with standard concepts, practices, and procedures within pharmacovigilance/drug safety.
- Perform internal ICSR quality review in safety database and provide timely feedback to management and vendor(s).
- Contribute to the review and content for regulatory submissions.
- Strong understanding of FDA processes, guidelines, requirements, and PV regulations.
- Relies on experience and judgment to plan and accomplish goals.
- Responsible for real-time monitoring and the review of complaints and adverse event cases.
- Performs a variety of tasks as identified by management.
- Works with cross-functional groups to collect information necessary for regulatory filings.
- Interact with all levels of site management (Vice Presidents to supervisory levels).
- Work under general supervision. Must have the ability to work both independently and within a team in a fast-paced environment to achieve business objectives.
- Recognize issues that should be brought to management.
Qualifications (Education & Experience)
- Minimum requirement: Bachelor's degree in a scientific field and at least 3 – 5 years of direct experience in pharmacovigilance/drug safety.
- Knowledge and experience in cGCP, PV regulations, and FDA requirements.
- Excellent English oral and written communication skills.
- Excellent organizational skills.
- Must be detail-oriented.
- Previous experience in the preparation of pharmacovigilance reports.
- Knowledgeable in the use of MedDRA.
- Strong experience with CTD format and content of regulatory filings.
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