Pharmacovigilance (PV) Scientist

Please contact
Renu Goel
857-207-2676
renu.goel@yoh.com


Pharmacovigilance (PV) Scientist
Contract (11 months) with perm potential
Cambridge, MA:  Hybrid (2 days onsite)
Pay rate:  $80 $85.00 per hour (depending on experience

***As per the hiring manager for this role, top skills and experience (recent experience shown on the resume) should include:  PSUR, DSUR for aggerate reporting, ARGUS and Empirica.

***Candidates must have a clinical background and coming from a very analytic and authoring role. 

Other experience required: A minimum of 3 – 5 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 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
• 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
• Assist in the evaluation of potential safety issues and quality risk assessment reports utilizing all processes and templates utilized by company and contribute to activities related to 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.
• Strong planning, organization, written and oral communication skills
• Experience in clinical patient care a plus
  

Special Skills: Ability to represent the functional department as internal and external contact on contracts and delivery for services relating to drug safety risk management.

• Manage cross-functional briefings and technical meetings for project stakeholders and customer representatives.
• Demonstrates diplomacy, reasoning, and problem-solving skills
• Negotiation skills encouraging discussion and driving decisions to desired results.
• Strong analytic and scientific writing abilities.
  

Job Complexity: Involved Aggregate Report Management and in RMP across the product life cycle.

• Managing through cross-functions, business partners and CROs.
• Responsible for the successful implementation and management of activities contributing to risk management.
  

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

Estimated Min Rate: $59.50
Estimated Max Rate: $85.00

Note: Any pay ranges displayed are estimations.  Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description.  All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.  All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.