PV Scientist

Integrated Resources, Inc ( IRI ); Cambridge (MA); On-site; USD 110,000 - 170,000; Full time

Job summary

Integrated Resources, Inc (IRI) in Cambridge, MA, seeks an experienced pharmacovigilance professional to analyze safety issues and lead signal management under the safety lead physician.

The role collaborates with cross-functional teams, develops Safety Management Plans, supports DRMP/RMP, and contributes to aggregate reports and SOPs to ensure global regulatory compliance.

Qualifications

• Five to seven years in the pharmaceutical industry with drug safety/pharmacovigilance experience.
• Experience managing drug safety personnel is a plus.
• Advanced knowledge of global pharmacovigilance regulatory requirements.
• RNA therapeutics experience is an advantage.
• Ability to work in a matrix environment with leadership commitments and values.
• Strong planning, organization, written and oral communication skills.
• Regulatory inspection readiness experience is a plus.

Responsibilities

• Collaborates with safety lead physician to analyze potential safety issues and manages signaling activities.
• Contributes to signaling and data mining using internal and external data sources.
• Assists in the development of Safety Management Plans.
• Supports data analysis compilation and presentation at cross-functional meetings.
• Assists in evaluating potential safety issues and risk management activities.
• Supports development and management of SOPs, templates, and risk communications.
• Assists in RMP and DRMP development and updates; authoring aggregate safety reports with safety lead.
• Supports cross-functional reporting and safety committee activities.

Skills

Pharmacovigilance

Regulatory knowledge

Signal detection

Communication skills

RNA therapeutics

Clinical care

Matrix environment

Inspection readiness

Education

PharmD/MD/RN

Tools

Empirica

Job description

• Works closely with the safety lead 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
• Assists in evaluation and development of Safety Management Plans
• Assists in data analysis compilation and presentation at cross-functional meetings.
• Assists in the evaluation of potential safety issues.
• Contributes to activities related to the functioning of Client 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.
• Contributes to the development and management of SOPs, work practices and guidelines, forms and templates, and other communications related to risk management and product safety.
• Assists in RMP and DRMP development and updates.
• Supports authoring for aggregate safety reports (eg.PSUR, DSUR, Line listings) in close collaboration with the safety product lead and operational functions

Qualifications

Education : Degree in a medical or healthcare related discipline (PharmD, RN, MD) is required

Experience : A minimum of five to seven years in the pharmaceutical industry with experience in drug safety/pharmacovigilance. Previous experience in managing drug safety personnel a plus. Specific experience in RNA therapeutic area at a global level is an advantage.

Strong skills and experience in :

Ability to work in a matrix environment in accordance with the company leadership commitments and values.

Excellent planning, organization, written and oral communication skills

Advanced knowledge of Global (including US, EU, LATAM, APAC) Pharmacovigilance regulatory requirements

Understanding Signaling tools (eg. Empirica)

Experience in clinical patient care is a plus

Regulatory Inspection readiness experience is a plus

Supervision: Individual is expected to work independently with support from management and colleagues in SRM.