R&D Partners is seeking to hire a Pharmacovigilance Scientist in Cambridge, MA.
Your main responsibilities as a Pharmacovigilance Scientist:
- Works closely with the safety physician to analyze potential safety issues, including signal detection, signal evaluation and signal management
- Contribute to signaling and data mining activities utilizing internal and external sources of data
- Performs signaling data review from all sources including but not limited to: Empirica, Clinical and Safety outputs, Literature, and HA requests
- Assist in the evaluation of potential safety issues and quality risk assessment reports utilizing all processes and templates
- Together with safety physician manages leads the authoring for aggregate safety reports (e.g. PSUR, DSUR, Line listings) in close collaboration with the cross functional lead and operational functions
- Supports all SRMT preparation and documentation with guidance from mentor and safety physician
- Working with affiliate management and regulatory to develop and edit SMPs/ESRPs and independently bringing issues related to SMPs and ESRPs for discussion with impacted parties
- Contribute to activities related to the functioning of safety committees, including but not limited to, preparing reports, minutes, and meeting documents; ensuring completion of action items; and participating in the discussion of patient safety issues
What we are looking for in a Pharmacovigilance Scientist :
- Degree in a medical or healthcare related discipline (MSN RN, PharmD, Physician Assistant, MD) is required
- A minimum of three to five years in the pharmaceutical industry with experience in drug safety/pharmacovigilance
- ARGUS and Empirica PSUR, DSUR for Aggerate reporting
- Must have clinical background
- Authoring experience
- Very analytic
Why Choose R&D Partners?
As an employee, you have access to a comprehensive benefits package including:
- Medical insurance PPO, HMO & HSA
- Dental & Vision insurance
- 401k plan
- Employee Assistance Program
- Long-term disability
- Weekly payroll
- Expense reimbursement
- Online timecard approval
Salary:
- $74.98 to $81.50 (Dependent on Experience)
R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
R&D Partners is an equal-opportunity employer.