|Location||Boston, Massachusetts, United States|
|Sector||Pharmaceuticals & Biotechnology|
Concilium are partnering with a small, rapidly growing oncology company based in Massachusetts. The company is developing novel, first in class agents and has recently received FDA approval for their first product.
The Senior Medical Director, Pharmacovigilance (PV) will provide broad support of activities requiring medical safety input for assigned products, pre- and post-approval. He/she will support and/or lead periodic safety signaling reviews and meetings, as well as perform individual and aggregate case review. He/she will also participate, in varying degrees, on clinical teams/programs and other intra and/or inter-departmental activities and initiatives.
- Represent department as medical safety lead on 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.
- Lead preparation and review of periodic reports (IND, Annual Safety, DSUR, PBRERs, 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 collection, evaluation and processing of adverse experience reports, from a medical perspective.
- Provide a contributory role in Partner /Affiliate agreements and interactions, as needed.
- As directed by the PV Head, assume primary responsibility/chair for the conduct of one or more Safety Team(s) for assigned products.
- Lead the regular review of safety data for assigned products for the identification of new safety signals, in accordance with signal detection practices.
- Provide Risk Management Strategy.
- Other activities, as needed or as requested by manager.
- MD, DO or equivalent ex-US medical degree.
- Minimum of 8 years' expereince in Drug Safety/Pharmacovigilance or Medical Monitor experience.
- Solid knowledge of General Medicine, MD, DO, MBBS.
- Adequate knowledge of GCP, ICH and Global regulations.
- Experienced in the evaluation and interpretation of data.
- Ability to multi-task.
- Solid written and oral communication skills.
- Solid judgment and decision-making skills, including the identification and communication of relevant safety- related issues or concerns to Medical Safety Management in an appropriate and timely manner.
- Experienced in safety reviews of AEs/SAEs, IBs, protocols, clinical study reports, informed consents, and other safety-related documents.
- Close attention to detail.