Senior Manager, PV Scientist
CultureHQ
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $160,000 - $190,000 per year
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- 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.
Requirements
- 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.
Benefits
- Competitive pay
- Performance-based bonus
- Stock options
- Insurance coverage (health, dental, life, and disability)
- Competitive time-off
- 401(k) plan
- Commuter/parking benefits
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Pharmacovigilancesignal detectiondata analysisaggregate safety reportssafety signaling activitiesMedDRA terminologyclinical trial protocolsInformed Consent FormsClinical Study Reportsregulatory responses
Soft skills
analytical abilityproblem-solvingorganizational skillscommunication skillscollaborationadaptabilitymulti-taskingpresentation skills