Clinical Safety Associate (NJ)-several positions
The Medical Reviewer reviews safety data from case report forms, interfaces with the clinical team and generates safety-related queries. This includes assuring and tracking 100-day medical review, coding all adverse events, collecting and reporting serious adverse events and ensuring the SAE database match. This person provides training on safety and CRF completing at investigator meetings, writes patient narratives, addresses data management queries, reviews protocols for safety elements and serves as Safety contact for SAEs in the protocol. We require at least two years of experience in drug safety with an RPh, PharmD or a health science degree.

apply for this job now
or
email us your resume (include the title and location of the job)

Manager, Pharmacovigilance (NY)
Responsible for writing Periodic Safety Update Reports (PSURs) which includes establishing project deadlines and monitoring project flow to ensure that the reports are submitted within required timeframes; determining appropriate safety database searches required for the PSURs; facilitating safety review meetings for assigned therapeutic categories; organizing and managing the collection of relevant data from contributors; review, analysis and integration of safety data of company products into PSURs; establish relationships with internal contacts. Requirements: BS (in a medical science), PhD, PharmD with 1-2 years of pharmaceutical experience.

apply for this job now
or
email us your resume (include the title and location of the job)

Medical Director (IL, CA, NY, NJ, MA)
We need several drug safety physicians (clinical and post-marketing) to monitor and summarize incoming adverse events and provide medical review/causality assessment of data. This position will interact with various inter-departmental group to ensure adequate capture and analysis of data.

apply for this job now
or
email us your resume (include the title and location of the job)

Director, Pharmacovigilance (NY)
The Director of Pharmacovigilance is responsible for overall performance of the team and maintaining compliance with established contracts with licensing partners. This person will be the primary liaison with licensing partners and will be the point person for various company departments, disseminate all safety related issues with regard to licensed products to management, manage data exchange process with licensing partner. Requirements: RN, PharmD, RPh with 5 or more years in drug safety.

apply for this job now
or
email us your resume (include the title and location of the job)

Product Safety Specialist (NJ)
Responsible for receipt and documentation of safety information for marketed and investigational products; Interacts with health professionals and consumers to obtain and follow-up reports of possible adverse events with company products ;Provides product information to health care professionals; consumers; and sales representatives Codes and enters information into the global safety database; Verifies the accuracy/completeness and validity of information for each adverse event report for which he/she is responsible; Assures consistency of case records and documentation ; Creates individual regulatory reports for FDA submission; Interfaces with other company departments for dissemination of drug safety information. Requirements: 5 years of experience 5 years' experience in an industry application of clinical medicine/pharmacy. BS, RPh, PharmD.

apply for this job now
or
email us your resume (include the title and location of the job)

Assistant Director, Pharmacovigilance (Midwest)
This candidate will be responsible for overseeing the preparation of PSUR reports in accordance with company and FDA guidelines. This individual will be the direct report for individuals responsible for PSUR compilation. Requirements: RN, RPh, MD PharmD with 3-5 years of pharmacovigilance, including people management.

apply for this job now
or
email us your resume (include the title and location of the job)

Medical Research Associate (MA)
Under general supervision, the Medical Research Associate I processes Serious Adverse Event (SAE) reports; provides general administrative support for Data Monitoring Committees (DMC) and company safety and surveillance activities; reviews coding; collates reports; and serves as a point of contact for medical information requests. Duties include but are not limited to: processes SAE reports; writes project-specific SAE reporting procedures; prepares DMC documents; coordinates travel and DMC meeting arrangements; takes, compiles and distributes DMC meeting materials; reviews data coding as requested by Clinical Data Management; responds to internal requests for medical information.

Required qualifications: Bachelor's degree; basic understanding of medical terminology; strong word processing skills; strong written and verbal communication skills; ability to organize and prioritize multiple tasks; ability to identify and search medical databases; ability to take direction and follow Standard Operating Procedures; ability to work independently and as a team player. Must be detail oriented; able to meet deadlines; have a professional demeanor and appearance.

apply for this job now
or
email us your resume (include the title and location of the job)

Medical Director (NY)
The Medical Director is responsible for all pharmacovigilance/risk management activities relative to his/her assigned products. The Medical Director initiates & directs or performs all activities necessary for anticipating, detecting & analyzing product-specific saftey issues &/or signals, & for coordinating the response to regulators; assess the labeling implications of the safety data generated in clinical trials; Provide direction & support for the development of various worldwide regulatory reports. Requirements: MD/DO with 5 years of industry experience.

apply for this job now
or
email us your resume (include the title and location of the job)