Pharmacovigilance Scientist Job at Stark Pharma Solutions Inc, Massachusetts

SzYzaEhLUVBtU21FbUVuM0k4OHlLVEtKZHc9PQ==
  • Stark Pharma Solutions Inc
  • Massachusetts

Job Description

Job Title: Pharmacovigilance Scientist

Location: Onsite in Waltham, MA (3 days per week)
Experience: 5+ years

Duration: 12+ months contract with strong potential for extension Overview

We're seeking an experienced Pharmacovigilance Scientist to lead safety surveillance and risk management activities for both investigational and marketed products. This role is key to ensuring the integrity and accuracy of safety data, working closely with the Safety Physician/Medical Monitor and cross-functional teams to meet global pharmacovigilance requirements.

Key Responsibilities
  • Lead and manage ongoing safety surveillance, signal validation, and aggregate reporting (PSUR, PADER, DSUR)

  • Conduct literature reviews and prepare materials for safety governance meetings

  • Handle ad hoc safety queries and regulatory authority requests

  • Support clinical development activities, including IB updates, DSMB presentations, CRF/ICF development, and safety narratives

  • Ensure compliance with evolving global pharmacovigilance regulations, SOPs, and internal quality standards

Required Qualifications
  • Minimum 3+ years of experience as a Pharmacovigilance Scientist

  • Minimum 5+ years in pharmaceutical, medical, or clinical research roles

  • Advanced degree preferred: PharmD, RN, MD, PhD, MPH, or NP

  • Strong analytical and writing skills with proficiency in Excel

  • Background in mental health or neurology therapeutic areas

Preferred / Bonus Skills
  • Familiarity with MedDRA , Argus Safety , and safety database systems

  • Strong project management, communication, and leadership skills

  • Ability to work both independently and collaboratively within multidisciplinary teams

Job Tags

Contract work, 3 days per week,

Similar Jobs

Actalent

Ai engineer Job at Actalent

AI Engineer Supporting Medical Devices!Job DescriptionWe are seeking a talented Software Engineer responsible for designing, developing, and deploying artificial intelligence and machine learning models that enhance our products and support systems. This role encompasses... 

Emergency University

Entry-Level Graphic Designer Job at Emergency University

 ...We are seeking a talented and creative Entry-Level Graphic Designer to join our team. This is a full-time position, with 40 hours per week.You will be responsible for creating visually appealing and effective designs. You will work closely with our Senior Graphic Designer... 

Unilever

Packaging Equipment Engineer - Beauty & Wellbeing Job at Unilever

 ...Change Catalyst". Emphasis will be to deliver business value and engineering solutions through your technical expertise. You will have...  ...and providing guidance on the Strategic elements of the site packaging systems and the development of our Long-Term Technology Plan.... 

Captain D's

Hospitality Specialist Job at Captain D's

 ...We are looking for a qualified and responsible Hospitality Specialist to manage all transactions with our customers efficiently and accurately. A good job candidate is a person who is willing to learn their way around our register and can easily operate it. Their main... 

AristaCare Cherry Hill

Activities Director Job at AristaCare Cherry Hill

 ...The Activities Director is responsible to plan, organize, develop, and direct the overall operation of the Recreation/ Activity Department in accordance with current federal, state, and local standards, guidelines and regulations, our established policies and procedures...