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Pharmacovigilance Manager
5 months ago
Join us at the forefront of rare disease research. Our client is a clinical-stage company developing gene therapies for multiple rare childhood diseases. They place enormous value on people, and consider the progress and well-being of their team members to be as important as the progress of their pipeline. For this role, they are looking for hands-on individuals who enjoy collaborating with colleagues, and who share a passion making a difference for patients. This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator.
As the Associate Director of Pharmacovigilance, you'll provide the expertise needed to review safety information, identify potential safety signals, and lead safety activities for assigned programs. You'll also prepare and review aggregate safety documents and regulatory filings.
This role requires a MD and is hybrid onsite.
Key Responsibilities:
- Lead safety activities for assigned programs.
- Provide medical input and review aggregate reports.
- Evaluate adverse events and provide company causality assessment.
- Prepare responses to safety queries from regulatory authorities.
- Support safety strategy preparation for pre-submission meetings.
- Represent Pharmacovigilance in clinical development projects.
- Participate in the signal management system.
- Conduct medical evaluation of relevant safety-related information.
- Participate in leadership oversight of safety vendors.
- Support preparation for regulatory inspections.
Qualifications:
- MD required. Experience in hematology/oncology or related specialty desirable.
- 7 years in Pharmacovigilance or relevant pharmaceutical or biomedical field.
- Knowledge of Pharmacovigilance and ability to apply knowledge to evaluation of safety concerns.
- Understanding of regulatory requirements for safety assessment and action.
- Strong scientific analytical reasoning skills.
If you encounter any difficulties in applying or have questions, please reach out to Nicole Leinders at Nicole.Leinders@gqrgm.com.
GQR is a specialized talent solutions provider, offering job opportunities in major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. GQR is an equal opportunity employer.
