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Sr Pharmacovigilance Scientist Jobs USA @ Biogen

Sr Pharmacovigilance Scientist Jobs USA @ Biogen: Biogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients with neurodegenerative diseases, hematologic conditions and autoimmune diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia.

Founded in 1978, Biogen is one of the world’s oldest biotechnology companies. Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options. These include programs for secondary progressive MS, Alzheimer’s Disease, spinal muscular atrophy, lupus and amyotrophic lateral sclerosis (ALS), amongst others.

With approximately 7,500 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.

Sr Pharmacovigilance Scientist Jobs USA @ Biogen

Job Description

The PV Scientist team is a critical group within the Safety and Benefit Risk (SABR) department at Biogen. The PV Scientist team is responsible for activities associated with aggregate reporting, safety signal management and responding to safety questions from internal and external stakeholders. PV Scientist role is critical for supporting the safety of Biogen products throughout the product life cycle. The ideal candidate for the PV Scientist role will have excellent written and verbal communication skills; demonstrated presentation skills; and extensive medical writing, editing, and source document review.

PV Scientist Responsibilities:

  • Assists with assessments of potential safety signals for safety physician review; involves synthesis of data from multiple sources and critical thinking skills as well as authoring monthly signaling reports.
  • Prepare and author reports of aggregate safety data such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and EU Risk Management Plans.
  • Key member of the Product Surveillance Team, including setting agenda, producing necessary data outputs, facilitating discussions, documenting conclusions.
  • Works closely with SABR Clinical Trial Physicians and Global Safety Officers on data analysis, signal detection, ad hoc requests and other product activities, as assigned.
  • Coordinates and authors responses to regulatory agencies in collaboration with safety physician; includes proposing a strategy for the response, review of relevant data, and authoring responses.
  • Represents SABR and/or Pharmacovigilance on study teams, cross function product teams, etc.
  • Supports safety activities for clinical trials, including protocol review, study team representation, document authoring, etc.

Qualifications | Sr Pharmacovigilance Scientist Jobs USA @ Biogen:

  • Ability to understand, interpret, analyze, and clearly present scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology).
  • Able to interact collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues
  • Able to develops and conduct, independently and/or collaboratively, all aspects of substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests.
  • Able to apply clinical judgment to interpret case information.
  • Strong Pharmacovigilance and drug development foundation, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes basic 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.
  • Assists with assessments of potential safety signals for safety physician review; involves synthesis of data from multiple sources and critical thinking skills as well as authoring monthly signaling reports.
  • Prepare and author reports of aggregate safety data such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and EU Risk Management Plans.
  • Key member of the Product Surveillance Team, including setting agenda, producing necessary data outputs, facilitating discussions, documenting conclusions.
  • Works closely with SABR Clinical Trial Physicians and Global Safety Officers on data analysis, signal detection, ad hoc requests and other product activities, as assigned.
  • Coordinates and authors responses to regulatory agencies in collaboration with safety physician; includes proposing a strategy for the response, review of relevant data, and authoring responses.
  • Represents SABR and/or Pharmacovigilance on study teams, cross function product teams, etc.
  • Supports safety activities for clinical trials, including protocol review, study team representation, document authoring, etc.

Education | Sr Pharmacovigilance Scientist Jobs USA @ Biogen

  • Academic degree in biological or natural science or health care discipline (e.g. PhD, MPH, NP, Pharm D, MSc)
  • Minimum 3 years of industry experience working in the pharmacovigilance discipline

Location : Cambridge, MA, US

Job Category : Drug Safety

Requisition Number : 28081BR

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.

Please be advised that all legitimate correspondence from a Biogen employee will come from “@biogen.com” or “@biogenidec.com” email accounts.

Sr Pharmacovigilance Scientist Jobs USA @ Biogen

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View Original Notification: https://jobs.biogen.com/job/Cambridge-Sr-Pharmacovigilance-Scientist-MA-02138/341456000/

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