Senior pharmacovigilance Scientist Consultant

Senior Pharmacovigilance Scientist Consultant

As part of our development, we are recruiting a Senior PV consultant to join our teams.

Responsibilities

• 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.
• Leads signaling review process and product Safety Signaling Team meetings.
• Provides safety leadership to cross functional project meetings.
• Leads process for responding to safety questions from regulatory authorities.
• Provides strategic input to the authoring of regulatory documents such as PSURs, DSURs, PADERs, Addendum to Clinical Overview.
• Leads development of Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and Risk Management Plans (RMPs) including providing safety input to post authorization safety studies (PASS) and additional risk minimization measures.
• Leads development of the strategy for medical and scientific literature review for safety information.
• Provides safety leadership to regulatory submissions in collaboration with the Global Safety Officer.
• Maintains an up to date understanding of relevant global safety regulations and guidelines.
• 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.
• Leads initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management and responding to ad hoc safety questions.
• Direct supervision of PV Scientist(s) including hiring, training and mentoring.

Seniority Level

Associate

Employment Type

Full-time

Job Function

Analyst

Industries

Pharmaceutical Manufacturing

CONSULTYS is open to all talents and is committed to diversity and inclusion.

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