Drug Safety & Pharmacovigilance (Pv) Scientist

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.

• 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.

How to Apply

To apply, please submit your cover letter and resume to Recruiting@pmvpharma.com or apply through our Online Portal.

PLEASE, NO PHONE CALLS or AGENCIES

PMV Pharmaceuticals is an Equal Opportunity Employer and all applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.