PV Aggregate Report Scientist

Pride Health; Cambridge (MA); Hybrid; USD 96,000 - 107,000; Full time

Benefits offered by this job

Healthcare coverage

401(k) retirement plan

Life & disability insurance

Employee discounts

Job summary

Pride Health is seeking a PV Aggregate Reports Scientist for a hybrid contract in Cambridge, MA. The role focuses on leading the preparation of PSURs, DSURs, PADERs, and other aggregate safety reports within the SSA team.

The candidate should have at least 5 years of Pharmacovigilance experience, strong knowledge of regulatory reporting, and proficiency with PV databases and MS Office tools. Collaborative, cross-functional work is essential.

Qualifications

• 5+ years of Pharmacovigilance experience, including aggregate safety report writing.
• Experience with global aggregate reporting requirements and PV processes.
• Knowledge of PSUR, PBRER, DSUR and local reporting requirements.

Responsibilities

• Lead and author PSURs, DSURs, PADERs, and local aggregate safety reports.
• Serve as 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 and PV process improvements.

Skills

Aggregate safety reports

Safety signal management

PSUR/PBRER

DSUR

Regulatory reporting

Data interpretation

PV processes

Education

Bachelor's degree in Biological/Natural Sciences

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

Tools

Excel

PowerPoint

Word

Business Objects

Job description

Pride Health is supporting a leading biotechnology organization with a hybrid contract opening for a PV Aggregate Reports Scientist within the Safety Surveillance and Aggregate (SSA) Reports team in Cambridge MA.

Job Details

• Schedule: Mon to Fri
• Location: Cambridge, MA (HYBRID)
• Job Type: Contract
• Contract Length: 12 months
• Pay Range: $70/hr - $78/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.

Pride-Health offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), 401(k)-retirement savings, life & disability insurance, an employee assistance program, legal support, auto, home insurance, pet insurance and employee discounts with preferred vendors.

Equal Employment Opportunity

Pride-Health is 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

Pride-Health is 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.

#JD-SCIENCE

#PHC

PrideGlobal and it's affiliates offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), 401(k)-retirement savings, life & disability insurance, an employee assistance program, legal support, pet insurance and employee discounts with preferred vendors.

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.