Job Description
This is a remote home/office-based position. Description: The Pharmacovigilance (PV) Scientist, reporting to the Head of Drug Safety & Pharmacovigilance is responsible for providing operational and scientific contributions for the Drug Safety/ Pharmacovigilance and Risk Management activities related to PMV’s product portfolio.
Responsibilities: - Maintain oversight of the safety Clinical Research Organization (CRO) and the day-to-day management of the safety CROs activities.
- Review and update or develop (as needed) Safety Management Plans and Risk Management Plans related to product safety. Ensure that the activities of these plans are being conducted.
- Provide support to the collation of information and inclusion in the safety database, within specified timings for the sponsor/company medical evaluation of serious adverse event/adverse events of special interest reports, as part of the sponsor evaluation of case processing conducted by the drug safety/pharmacovigilance CRO(s).
- Support the generation of SAE/AESI queries and tracking including oversight in the query resolution escalation efforts.
- Liaise with company interdepartmental personnel and participate in the planning and appropriate safety data collection activities for company sponsored studies.
- Ensure quality and compliance metrics are being met and work closely with company quality assurance department to identify and manage quality issues related to pharmacovigilance.
- Participate and support the Head of Drug Safety & PV for the conduct and documentation of the Safety Management Team meetings.
- Participate or support preparation of clinical study-level Safety Review Committee meetings.
- Participate in the evaluation of the cumulative or interval adverse event and other safety information thoroughly and in a timely manner and support as needed in the reporting of such information in accordance with institutional and local health authority requirements.
- Contribute and maintain the departmental SOPs, work instructions as applicable in preparation and support of company internal audit or regulatory inspections.
- Contribute to the preparation of Reference Safety Information, safety sections of the Investigators Brochure, CCDS as appropriate, and communicate identified risks to internal and external stakeholders, as appropriate.
- Assist in the preparation and review of safety sections of clinical documents such as annual safety reports such as Development Safety Update Reports (DSURs).
- Provide input and review of responses to regulatory agency questions with regard to safety/ pharmacovigilance activities.
Requirements:
- Master’s degree as a healthcare professional is preferred.
- Pharmacovigilance minimum 4 years of experience within pharmaceutical industry preferred. Oncology experience is a plus.
- Demonstrated knowledge of experience of PV vendor/CRO oversight.
- Demonstrated knowledge of expertise in safety data analysis and signal management.
- Demonstrated knowledge of relevant regulatory agency(s) guidelines governing both Safety reporting and processing for clinical trial environments.
- Demonstrated knowledge of supporting internal audits, inspection readiness and regulatory agency(s) inspection support for clinical trials including BLA or NDA approval inspections.
- Excellent communication and analytical skills (written and oral).
- Excellent judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way.
- Ability to work in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient.
Benefits :
- PMV provides a competitive medical benefits package, a generous PTO policy, competitive salaries, Employee Stock Purchase Plan, Employee Referral Program, and much more.
Job Tags
Full time, Local area, Work from home, Home office, Flexible hours,