Pharmacovigilance (PV) Scientist-Hybrid

Pharmacovigilance (PV) Scientist

Location: Cambridge, MA

Contract: 12 months (could extend)

Pay: $80 hr.

Seeking candidates with: ARGUS and Empirica PSUR, DSUR for Aggerate reporting (Recent Exp shown on the resume) Must have clinical background Very Analytic and Authoring role.

Job Description:

• Works closely with the safety physician to analyze potential safety issues, including signal detection, signal evaluation and signal management. Collaborates proactively with study teams, cross-functional team members, external business partners and vendors to apply knowledge and analytical skills to problems in specific therapeutic areas.
• 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
• Develop knowledge of capabilities and limitations of various data sources.
• Assist in the evaluation of potential safety issues and quality risk assessment reports utilizing all processes and templates
• 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.
• Proactively disseminates information to safety team members, providing context/urgency as applicable.
• Communicates clearly to all cross-functional areas including scheduling meetings to provide clarity and resolution of issues.
• 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.
• Identifies gaps in overall processes and initiates change as appropriate.

Education:

• Degree in a medical or healthcare related discipline (MSN RN, PharmD, Physician Assistant, MD) is required

Experience:

• A minimum of three to five years in the pharmaceutical industry with experience in drug safety/pharmacovigilance.
• Supporting the development and application of business process improvement methodologies and/or developing ideas into practical business solutions
• Ability to work in a matrix environment in accordance with the company leadership commitments and values. Preferably with experience of working across diverse geographic areas, business settings and cultures.
• Pharmacovigilance, safety, or clinical science, and/or other relevant areas of clinical biopharmaceutical development or medical affairs.
• Knowledge of Argus, Arisg Safety Databases
• Knowledge of Signaling tools (e.g., Empirica, Spotfire)
• Experience and or understanding of regulations in the pharmaceutical industry.
• Skills in developing/implementing data displays (Dashboards) of data for signaling, compliance and departmental KPIs & QPIs
• Knowledge of Global (including US, EU, LATAM, APAC) Pharmacovigilance regulatory requirements

After you have applied, download our Staffmark Group WorkNOW App to receive real-time job offers and apply for additional opportunities. You can download it from the App Store or get it on Google Play.

With company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing - delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visit AdvantageTechnical.com.

Advantage Technical is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact your local branch. Advantage Technical is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.

All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.