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Pharmacovigilance Safety Scientist job

Barrington JamesParamus, NJ
Barrington James jobs

Company

Company Description

Barrington James is an international recruiting firm that provides human resource solutions partnering with the pharma, medical devices, and healthcare industries across the globe. The firm offers various services in areas such as contingency recruitment, contract and interim recruitment, global executive search, retained campaign management, and talent alliance. Barrington James caters to medical devices, life science, biotechnology, and pharmaceutical sectors.
The company provides highly competitive pay packages, healthcare benefits, and other perks to its employees. Barrington James was founded in 2002, and its headquarter is based in Crawley, United Kingdom.

Job Description

  • The PV Safety Scientist serves as a product lead for PV activities within the GPV & RM, Aggregate Safety Reporting function (e.g., strategy, author, review, publication) for DSURs, PBRER/PSURs, Pharmacovigilance Plans, REMS, RMPs and Ad Hocks.
  • Leads in aggregate report responses to safety questions from internal and external stakeholders, with GSL input and reviewing medical and scientific literature for safety information and supporting Clinical Trial PV medical activities such SMPs.
  • Supports the GSL Physician in the signal management process (e.g., signal tracking, leading review meetings, maintains roster, calendar, and minutes/communication) 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. Leads signalling review process and collaborates with the GSL Physician for Product Safety Signalling Team meetings.
  • Serves as a SME for GPV and cross-functional teams on relevant global safety regulations and guidelines, data output and analyses, and product-specific information. Additionally, leads process for responding to safety questions from regulatory authorities.
  • Manages literature review for safety information and supports ad hoc regulatory safety requests by obtaining data from the clinical trial and global safety database as well as literature and assists the GSL Physician in determining the impact of newly identified safety issues on the product’s benefit/risk profile.
  • Provides support to GSL Physician in activities relating to monitoring and management of Product's emerging safety profile.
  • Supports the logistics of Safety Action Committee meetings, maintains roster, calendar, and minutes/communication.
  • Collaborates with GSL for assigned investigational programs including clinical trial activities (e.g., protocol review, ICF review) safety committee management, data analysis, signal detection, ad-hoc requests and other product activities, as assigned.
  • Contributes to and leads initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management and responding to ad hoc safety questions.
  • At least 4-6 years of experience in the pharmaceutical/ biotechnology industry in pharmacovigilance safety related role.
  • Ideally looking for a combination of experience including experience in aggregate safety reports and safety signal management. Strong background in clinical trial drug safety is required.
  • Excellent understanding of PV regulatory environment with working knowledge of FDA, EMA and ICH regulations, Guidance, best practices, and GPV&RM.
  • Understands, interprets, analyzes, and clearly presents scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology).
  • Demonstrates leadership and interacts collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues.
  • Leads and conducts, independently and/or collaboratively, all aspects of substantive projects such as signaling, authoring of aggregate data reports, and responses to Health Authorities’ requests. Oversees and mentors less experienced PV Safety Scientist staff.
  • Strong Pharmacovigilance and drug development foundation, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes knowledge of case processing, expedited reporting rules, and safety database concepts.
  • Strong organizational skills, including the ability to prioritize independently with minimal supervision.
  • Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects).
  • Knowledge of common safety database systems.
  • Organizational Relationship/Scope:
  • The PV Safety Scientist reports directly to the Director, Aggregate Pharmacovigilance and will operate independently under limited supervision and will participate in determining work objectives
  • The PV Safety Scientist will work closely with members of GPV& RM, Regulatory Affairs, Clinical Operations, Medical Information, Product Monitoring and Legal.

Barrington James

Type

Company - Private

Size

Small

Revenue

$10M to $25M

Location

Multiple locations

Founded

2002

CEO

Dan Barrington

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Medical Science Liaison - Women's Health West Coast USA OR Southern USA I am currently linked with an EU based Medical Device company looking to bring on experienced MSLs to promote their innovativeRead more
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Director Clinical Development Maryland, USA I am partnered with a clinical stage biopharmaceutical company focused on developing peptide-based therapeutics for Liver disease and Cancer, as well asRead more
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We are seeking an Admin Assistant to join our team! This position does not require legal experience although it is preferred for the candidate to have some legal experience or knowledge. You willRead more
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