Aggerate Reports Specialist

Planet Pharma; Cambridge (MA); On-site; USD 117,000 - 131,000; Full time

Job summary

Planet Pharma in the United States seeks an experienced PV professional to lead aggregate safety reporting activities, coordinating with cross-functional teams and regulatory partners to ensure timely and compliant PSURs, DSURs, and line listings.

The role involves overseeing line listing management, developing SMPs/ESRPs, driving process improvements, supporting safety committees, and mentoring staff in pharmacovigilance best practices across global regions.

Qualifications

• Minimum 3–5 years in pharmaceutical industry with drug safety/pharmacovigilance experience.

Responsibilities

• Lead authoring of aggregate safety reports (PSUR, DSUR, Line listings).
• Oversee line listings management for PV Science group and submissions.
• Develop SMPs/ESRPs with regulatory teams and stakeholders.
• Identify gaps in aggregate report processes and drive changes.
• Collaborate on signaling and data mining using multiple data sources.
• Provide training and guidance to new staff in safety practices.

Skills

Pharmacovigilance

Safety reporting

Data analysis

Cross-functional collaboration

Regulatory knowledge

Dashboard development

Education

Medical or healthcare related degree

Tools

Argus

Arisg Safety Databases

Empirica

Spotfire

Job description

Primary responsibilities:

• Together with Aggregate Report lead, PV Science lead, and Safety Physician manages and leads the authoring for aggregate safety reports (e.g. PSUR, DSUR, Line listings) in close collaboration with the cross functional lead and operational functions
• Oversees management of all line listings (6-month, 3-month, ad-hoc) for the PV Science group, including generation through submission
• Working with affiliate management and regulatory to develop and edit SMPs/ESRPs and independently bringing issues related to SMPs and ESRPs for discussion with impacted parties
• Identifies gaps in overall aggregate report processes and initiates change as appropriate

Other potential responsibilities:

• Works closely with the safety physician to analyze potential safety issues, including signal detection, signal evaluation and signal management. Collaborates proactively with study teams, cross-functional team members, external business partners and vendors to apply knowledge and analytical skills to problems in specific therapeutic areas.
• Contribute to signaling and data mining activities utilizing internal and external sources of data. Performs signaling data review from all sources including but not limited to: Empirica, Clinical and Safety outputs, Literature, and HA requests
• Develop knowledge of capabilities and limitations of various data sources.
• Assist in the evaluation of potential safety issues and quality risk assessment reports utilizing all processes and templates utilized by the company
• Contribute to activities related to the functioning of safety committees, including but not limited to, preparing reports, minutes and meeting documents; ensuring completion of action items; and participating in the discussion of patient safety issues.
• Proactively disseminates information to safety team members, providing context/urgency as applicable.
• Communicates clearly to all cross-functional areas including scheduling meetings to provide clarity and resolution of issues.
• Demonstrates alignment with companies core values
• Supports all SRMT preparation and documentation with guidance from mentor and safety physician
• Contribute to activities related to the functioning of safety committees, including but not limited to, preparing reports, minutes and meeting documents; ensuring completion of action items; and participating in the discussion of patient safety issues.
• Provide management and training for new staff on department practices and therapeutic area knowledge.

Education:

Degree in a medical or healthcare related discipline (MSN RN, PharmD, Physician Assistant, MD) is required

Experience:

A minimum of three to five years in the pharmaceutical industry with experience in drug safety/pharmacovigilance.

Strong skills and experience in;

• Supporting the development and application of business process improvement methodologies and/or developing ideas into practical business solutions.
• Ability to work in a matrix environment in accordance with the company leadership commitments and values. Preferably with experience of working across diverse geographic areas, business settings and cultures.
• Pharmacovigilance, safety, or clinical science, and/or other relevant areas of clinical biopharmaceutical development or medical affairs.
• Knowledge of Argus, Arisg Safety Databases
• Knowledge of Signaling tools (e.g. Empirica, Spotfire)
• Experience and or understanding of regulations in the pharmaceutical industry.
• Skills in developing/implementing data displays (Dashboards) of data for signaling, compliance and departmental KPIs & QPIs
• Knowledge of Global (including US, EU, LATAM, APAC) Pharmacovigilance regulatory requirements
• Strong planning, organization, written and oral communication skills
• Experience in clinical patient care a plus

Special Skills:

Ability to represent the functional department as internal and external contact on contracts and delivery for services relating to drug safety risk management. Manage cross-functional briefings and technical meetings for project stakeholders and customer representatives. Demonstrates diplomacy, reasoning, and problem-solving. Negotiation skills encouraging discussion and driving decisions to desired results. Strong analytic and scientific writing abilities.

Job Complexity:

Involved Aggregate Report Management and in RMP across the product life cycle. Managing through cross-functions, business partners and CROs. Responsible for the successful implementation and management of activities contributing to risk management.

Supervision:

Individual is expected to work independently with support from management and colleagues in GPSRM.

Pay ranges between 85-95/hr based on experience