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US_Drug Safety Consultant II

TalentBurst, an Inc 5000 company

Role overview

Qualifications

  • Minimum 7 years Pharmacovigilance experience, including experience in aggregate safety reports and safety signal management experience.
  • Bachelor's Degree in biologic or natural science; or health care discipline required. Advanced degree (PhD, MPH, NP, PharmD, etc.) preferred.
  • Knowledge of MedDRA terminology and its application.
  • Must have excellent analytical and problem-solving ability.

Responsibilities

  • Support and/or lead the signal management process for assigned product(s) and evaluate safety data and signals as part of ongoing pharmacovigilance activities.
  • Support and/or lead the process for responding to safety questions from regulatory authorities while collaborating with a cross-functional team.
  • Support and/or lead Aggregate Report management, including strategy, review, and finalization of aggregate safety reports for assigned products.
  • Collaborate with Global Safety Officers and other Safety MDs for assigned investigational programs including clinical trial activities, safety committee management, and data analysis.

Key facts

Hard skills

Pharmacovigilance Aggregation Analysis MedDRA Signal Handling

Other skills

  • Microsoft Excel
  • Analytical Skills
  • Problem Solving
  • Time Management

About the company

TalentBurst, an Inc 5000 company logo

TalentBurst, an Inc 5000 company

Human Resources, Staffing & Recruiting

Founded in 2002, TalentBurst is a certified MBE firm that provides award winning solutions globally including: IT/Eng, Prof, & F&A Staffing Life Sciences & Clinical Staffing SLED (State, Local, Education) Staffing High Hazard & Global Payroll 1099/IC Validation & Compliance Recognitions & awards include: 2023 Top Workplaces Best Place to Work 2023 Top Workplaces Culture Excellence 2023 World Staffing Summit Top 100 Staffing Firms to Work For 2023, 2022 SIA Diverse Owned Staffing Firms 2021 BBJ #1 Largest MBE Enterprise in MA 2020-2021 BBJ Fast50 2020 SIA Large Life Sciences Staffing Firms 10 time BBJ Pacesetter & INC 500/5000 5 time SIA-fastest growing GNEMSDC Supplier of Year Category 4 2019-2020 AgileOne Diverse Supplier of the Year 2021 AgileOne Gold Supplier 2017 Allegis Global Solutions Strategic Partner 2018-2023 Allegis Global Solutions Diversity Partner of the Year 2020 Coupa Advantage and Link Silver Partner Magnit Global Supplier Excellence 2023 PRO Unlimited Silver, Gold, & Platinum Supplier 2012-2020 PRO Unlimited VOP Supplier of the Year 2020 Randstad Premier Supplier 2021-2023 TAPFIN Premier Partner 2017-2018 Workforce Logiq Proven Performer 2016-2020 First Data #1 supplier for 12 Quarters Thermo Fisher Supplier of the Quarter Toyota Best in Compliance & Retention Excellence Dominion Energy Supplier of the Year 2020 Western Union Supplier of the Year 2017 Top Supplier for PerkinElmer, VISA, Mass Mutual, and more! We currently have workforce in 46 states & 12+ countries for customers such as Amazon, Apple, VISA, Exelon, Securian, Salesforce, Dropbox, Twitter, Otsuka, Adobe, Western Union, First Data, FIS, SANOFI, Merck, Abbott, Roche, Dell, and Corning among many others. We are headquartered in Natick, MA (Boston) along with operations in New Jersey, Virginia, North Carolina, Canada, India as well as remote Executives strategically placed nationwide. Check us out at www.TalentBurst.com or via Linkedin or Facebook

Company details

Company typeLarge
IndustryHuman Resources, Staffing & Recruiting
Company size1001 - 5000

Links

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Job description

Title: US_Drug Safety Consultant II/PV Scientist
Location: Remote
Duration: 6 Months

Description:
PV Scientist serves as a product lead for Pharmacovigilance activities within Safety. The PV Scientist may be responsible for overseeing day to day safety operations of clinical trials for the assigned product(s), supporting and/or leading the process for safety signal management activities, aggregate reports (PSURs, DSURs, Line Listings) and RMPs, responding to safety questions from internal and external stakeholders, reviewing medical and scientific literature for safety information, and supporting Clinical Trial PV activities. The PV Scientist also serves as a Subject Matter Expert for Safety and cross-functional teams on relevant global safety regulations and guidelines; data output and analyses; and product specific information.

What You'll Do
Support and/or leads the signal management process (i.e., signal detection, signal tracking, signal documentation, facilitating decisions regarding signals and safety risk, etc.) for assigned product(s) and evaluates safety data and signals as part of ongoing pharmacovigilance activities. Includes synthesis of data from multiple sources and authoring signal evaluation reports. Support and/or leads signaling review process and product Safety Signaling Team meetings. Manages literature review for safety information.
Support and/or leads process for responding to safety questions from regulatory authorities while collaborating with cross-functional team as necessary.
Support and/or leads Aggregate Report management, including strategy, review and finalization of aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Plans (REMS), and Risk Management Plans (RMPs).
Collaborates with Global Safety Officers and other Safety MDs for assigned investigational programs including clinical trial activities (protocol review, ICF review, etc.), safety committee management, data analysis, signal detection, ad hoc requests and other product activities, as assigned to ensure alignment with safety strategy and risk communications.
Responsible for day-to-day safety operations and safety management plans for assigned clinical trials
Qualifications Required Skills
  • Minimum 7 years Pharmacovigilance experience, including experience in aggregate safety reports and safety signal management experience.
  • Bachelor's Degree in biologic or natural science; or health case discipline required. Advanced degree (PhD, MPH, NP, PharmD, etc.) preferred.
  • Knowledge of MedDRA terminology and its application
  • Must have excellent analytical and problem-solving ability
  • Strong computer skills and advanced application MS capability desirable, particularly Excel
  • Ability to work in fast-paced environment with multiple competing priorities.

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Why TalentBurst?
At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.

Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.

We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.

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Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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