Senior Manager, PV Scientist

Role Summary

This is an exciting opportunity for a Pharmacovigilance professional who enjoys working in a dynamic fast paced environment. The Senior Manager, Pharmacovigilance Scientist plays a pivotal role within PV to develop and maintain safety assessments in accordance with the regulations and guidelines. The ideal candidate will provide scientific/clinical expertise, support for deliverables and activities associated with signal management, safety, and benefit-risk evaluations for assigned development compound(s). This role provides an excellent opportunity for close collaboration with colleagues from other functions such as Clinical Operations, Clinical Development, and Regulatory Affairs. Location: Waltham, MA; Boulder, CO.

Responsibilities

• Supports early-stage and late-stage development products.
• Oversight of day-to-day safety monitoring activities of clinical trials for the assigned product(s).
• Perform signal management activities including – signal detection, analysis, and tracking for the assigned product(s).
• Effectively collaborate with stakeholders outside of PV, including representing PV department in cross-functional clinical programs.
• Participate in Safety Committees (e.g., Safety Management Team and Independent Data Monitoring Committees meetings); may include coordinating data, slide creation, data presentation, agenda drafting, and minutes.
• Provides PV input for development of protocols, Investigator’s Brochure, Informed Consent Forms, Clinical Study Reports, and other relevant study documents.
• Contribute to authoring of aggregate safety reports, e.g., DSURs.
• Contribute to regulatory responses while collaborating with cross-functional areas as necessary.
• Participate in developing, implementing, and maintaining processes that are compliant with global PV regulations.
• Perform other tasks as assigned by the team.

Qualifications

• Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background and proven competence in Pharmacovigilance.
• Minimum 6 years’ relevant medical, scientific/clinical, or pharmaceutical experience, including experience in drug safety, serving in a PV scientist role.
• Experience in early and late-stage oncology trials preferred.
• Thorough understanding of safety signaling activities.
• Experience in signal detection activities with demonstrated experience in analysis, and interpretation of medical and scientific data.
• Knowledge of MedDRA terminology and its application.
• Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex information and safety data.
• Experience in the preparation and authoring aggregate safety reports.
• Knowledge of Pharmacovigilance regulations and guidelines including Good Pharmacovigilance Practices (GVP), Good Clinical Practices (GCP) and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
• Comfortable in a fast-paced, high-pressure company environment and able to adapt to changing priorities.
• Must have excellent analytical and problem-solving ability.
• Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
• Ability to communicate within the organization and present ideas both orally and in writing.