PV Aggregate Report Scientist

Russell Tobin; Cambridge (MA); Hybrid; USD 85.000 - 110.000; Vollzeit

Zusammenfassung

PrideGlobal and its affiliates partner with a global pharmaceutical organization to identify a PV Aggregate Report Scientist for a Cambridge, MA hybrid role.

The candidate will lead PSUR/DSUR/PADER reporting, serve as PV SME, and manage schedules with cross-functional teams to meet regulatory timelines. A strong pharmacovigilance background and expertise in safety signals are required.

Qualifikationen

• Direct experience with aggregate safety report writing and safety signal management.
• Strong knowledge of PSUR/PBRER, DSUR, PADER, and local reporting requirements.
• Knowledge of clinical trial and post-marketing safety regulations, case processing, expedited reporting, and safety databases.
• Strong scientific/medical data interpretation and communication skills.
• Proficiency with Excel, PowerPoint, Word, Business Objects; familiarity with PV safety databases.
• Education: Bachelor's degree in Biological Sciences, Natural Sciences, or related field; advanced degree preferred.
• Minimum of 5 years of Pharmacovigilance experience, including direct experience in aggregate safety report writing and safety signal management.
• Safety report writing and safety signal management.

Aufgaben

• Lead and author PSURs, DSURs, PADERs, and local aggregate safety reports.
• Serve as a Subject Matter Expert on global aggregate reporting requirements and PV processes.
• Manage aggregate report schedules, stakeholder reviews, and regulatory timelines.
• Conduct global regulatory/legislation reviews and provide impact assessments.
• Support Health Authority responses to safety inquiries.
• Collaborate with PV, Clinical, Medical, Regulatory, Quality, and external vendors.
• Support signal management, clinical trial safety oversight, and PV process improvements.
• Maintain and implement compliant global PV procedures and processes.

Kenntnisse

Safety report writing

Safety signal management

PSUR/DSUR knowledge

Regulatory knowledge

Ausbildung

Bachelor's degree in Biological/Natural Sciences or related field

Advanced degree (MSc/PhD/ MPH/ PharmD) preferred

Tools

Excel

PowerPoint

Word

Business Objects

PV databases

Jobbeschreibung

Russell Tobin is partnering with a global pharmaceutical organization to identify a PV Aggregate Report Scientist for an opportunity near Cambridge, MA.

Job Details

Schedule: Mon to Fri

Location: Cambridge, MA (HYBRID)

Job Type: 12 month contract

Pay Range Approved: $62/hr - $79.50/hr

Pay offered is based on experience,expertise, credentialing, and education.

Duties

• Lead and author PSURs, DSURs, PADERs, and local aggregate safety reports.
• Serve as a Subject Matter Expert (SME) on global aggregate reporting requirements and PV processes.
• Manage aggregate report schedules, stakeholder reviews, and regulatory timelines.
• Conduct global regulatory/legislation reviews and provide impact assessments.
• Support Health Authority responses to safety inquiries.
• Collaborate with PV, Clinical, Medical, Regulatory, Quality, and external vendors.
• Support signal management, clinical trial safety oversight, and PV process improvements.
• Maintain and implement compliant global PV procedures and processes.

Requirements

• Direct experience with aggregate safety report writing and safety signal management.
• Strong knowledge of PSUR/PBRER, DSUR, PADER, and local reporting requirements.
• Knowledge of clinical trial and post‑marketing safety regulations, case processing, expedited reporting, and safety databases.
• Strong scientific/medical data interpretation and communication skills.
• Proficiency with Excel, PowerPoint, Word, Business Objects, and familiarity with PV safety databases.
• Education: Bachelor's degree in Biological Sciences, Natural Sciences, or related field; advanced degree(MSc, PhD, MPH, PharmD, etc.) preferred.
• Years of experience: Minimum of 5 years of Pharmacovigilance experience, including direct experience in aggregate safety report writing and safety signal management.
• Skills/Specialties/Technology: Safety report writing and safety signal management.

Equal Employment Opportunity

PrideGlobal and it's affiliates are an equal opportunity employer. We do not discriminate on the basis of the race, religious creed, color, national origin, ancestry, physical disability, mental disability, reproductive health decision making, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, age, sexual orientation, veteran or military status, or any other characteristic protected by applicable federal, state, or local law.

Fair Chance Employment

PrideGlobal and it's affiliates are a Fair Chance employer. We consider all qualified applicants, including those with criminal histories, in a manner consistent with applicable state and local Fair Chance laws and ordinances, including, the California Fair Chance Act and all applicable local Fair Chance ordinances.

Accommodations

We are committed to providing reasonable accommodations to applicants and employees with disabilities. If you require a reasonable accommodation to participate in the application or interview process, or to perform the essential functions of this role, please contact us.

Only applicable for San Francisco Candidates: Under the San Francisco Lactation in the Workplace Ordinance, we will provide written notice of lactation accommodation rights, and this notice will automatically be given upon hiring, any inquiry of parental leave or lactation accommodation.

Only applicable for Kentucky positions: For this type of employment, state law requires a criminal record check as a condition of employment. This applies to direct care staff (Examples: RN, LPN, Nurse Aides, Therapists) referred to Kentucky nursing facilities, assisted living communities, or long‑term care facilities, in accordance with KRS 216.793.