Black Diamond Networks
Andover, MA, United States
Healthcare, Manager, 100k
Senior Medical Director
Life Sciences & Technology | Clinical Research & Clinical Affairs
The client is looking for a Sr. Medical Director to provide broad support of activities requiring medical safety input for assigned products, pre- and post-approval. This person will support and lead periodic safety signaling reviews and meetings, as well as perform individual and aggregate case review. They will also participate in clinical teams/programs and other inter-departmental activities and initiatives. This person would represent the PV department as medical safety lead on a cross-functional study and program teams for assigned products and studies, providing expert guidance regarding safety matters and issues.
Provide timely and sound medical review of individual case safety reports from clinical trials or post-marketing sources as needed.
Participate in protocol development, specifically the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans.
Participate in the analysis of safety data from on-going and completed clinical trials and representation in clinical study reports.
Contribute to the preparation and review of periodic reports (IND, annual safety, DSUR, PSURs, CSR).
Review and provide medical content, as needed, for key study-related documents, e.g. IB, ICF, IDMC Charter.
Participate in departmental development activities including SOP and work instructions development.
Provide guidance to staff regarding optimal practice regarding the collection, evaluation, and processing of adverse experience reports, from a medical perspective.
MD, DO, or equivalent.
Minimum of 6-8 years of drug safety/pharmacovigilance or medical monitor experience.
Solid knowledge of General Medicine, MD, DO, MBBS.
Adequate knowledge of GCP, ICH and Global regulations.
Prior NDA experience and oncology experience preferred.
Experienced in the evaluation and interpretation of data.
Experienced in safety reviews of AEs/SAEs, IBs, protocols, clinical study reports, informed consents, and other safety-related documents.
Black Diamond Networks
Phone : 800-681-4734
Website : http://www.blackdiamondnet.com
Black Diamond Networks connects companies and IT & Engineering contractors across the country. Our approach is simple, know the client, know the contractor, understand the need, and deliver. In short, create success.