The Medical Director will provide hands-on PV support for Sumitomo Dainippon Pharma Oncology’s investigational and commercial stage Oncology products. Responsibilities include routine PV surveillance, data assessment for aggregate safety reporting, and maintenance of the benefit/risk profile in a cross-functional team environment. There will be opportunities to provide PV subject matter expertise to clinical development activities such as updating program clinical study documents (e.g., protocols and Investigator’s Brochures) and writing Clinical Study Reports. Additionally, this person will be responsible for performance of Medical Review with support from an external partner.
- Perform routine PV surveillance activities such as signal detection and literature monitoring, with support from an external partner.
- Provide PV expertise to the writing or update of program documents such as protocols, Investigator’s Brochures (IBs), and Informed Consent Forms (ICFs).
- Participate in the cross-functional program team meetings that manage the overall benefit/risk profile of the compound.
- Complete data analyses and writing of responses to health authority queries as well as aggregate safety reports such as Development Safety Update Reports (DSURs) and Periodic Benefit/Risk Evaluation Reports (PBRERs).
- Perform Medical Review, possibly with support from an external vendor.
- Support the completion of Clinical Safety Reports (CSRs) by reviewing safety data, patient narratives, and safety sections of the documents.
- Contribute as needed to the preparation for Data Safety Monitoring Board meetings.
- Engage in activities to help build the PV department including, but not limited to, Medical Safety process refinement and training.
- Other duties as assigned.
- MD (or ex-US equivalent) or PharmD.
- Minimum of 3-5 years of experience in PV in the pharmaceutical industry.
- Prior experience with routine PV activities such as signal detection, literature monitoring, and aggregate safety reports writing is required.
- Prior experience performing Medical Review is required.
- Prior experience writing/updating protocols, IBs, and ICFs is required.
- Prior experience writing CSRs is a plus.
- Prior experience in Oncology strongly preferred.
- Experience working with vendors is strongly preferred.
- Knowledge of ICH, US & EU regulations and requirements for Pharmacovigilance.
- Excellent interpersonal skills, with demonstrated ability to work in a multi-disciplinary setting, foster/nurture teamwork, and act as a facilitator to drive fulfillment of strategic goals.
- Willingness to be very “hands-on” in a fast-paced work environment, and ability to reprioritize as needed.
- Strong communication skills with excellent written and spoken English.
Job Location: Cambridge, MA
Equal Opportunity Employer
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