Associate Medical Director
Proclinical is currently recruiting for an Associate Medical Director with a global pharmaceutical company located in Boston, MA. Successful candidate will support the Global Safety Lead for designated products or, as appropriate, undertaking a GSI role. Incumbent will also be responsible for oversight of signal detection and risk management activities for designated global products together with usual safety mandated remit.
- Supporting GSL role for compound(s) both in development and marketed in close association with the TAL.
- Intimate awareness of safety for his/her compound responsibilities, including any emerging safety concerns and risk/benefit profile.
- As appropriate, mentoring/involvement in a leadership capacity for complex and strategically important programs.
- Responsible for development of documents and for negotiation with Regulatory authorities on safety matters involving these compounds. This includes but is not limited to: direct interaction with Regulatory authorities, authorship of safety summaries to support changes to the PI/SmPC, significant contribution to MAAs and NDAs, authorship of Executive Summaries on special safety topics, authorship of Integrated Analyses of Safety (IAS) for CTDs, etc.
- Training and mentoring of Pharmacovigilance Physicians and Specialists.
- Perform activities required to serve as Global PV physician. Review and oversight of safety data, both non-clinical and clinical. Review and/or sign off of protocols, SAPs, clinical study reports, IBs, IMPD and other documents developed for submission to regulatory authorities. Interactions with external experts and regulatory agencies and partner/co-development companies.
- Maintain professional knowledge and accreditation by active participation in continuing medical education activities.
Skills and Requirements:
- Medical Degree required or internationally recognized equivalent.
- Minimum of 2-3 years' experience in pharmacovigilance, clinical research or clinical development.
- 1 year of clinical experience with patients following post-graduate training with significant knowledge of general medicine.
- Knowledge of principles of epidemiology and statistics.
- Critical thinking and analytical skills and ability to make high level decisions.
- Excellent oral and written communication skills including ability to present to large internal/external groups.
- Good level of computer literacy with Microsoft applications.
- US - Active license preferred.
- EU - registered to practice in the EU - preferred.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Mary Jacobs at (+1) 312-291-4181 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.