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Pharmacovigilance (PV) Scientist
Job Description
• •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 core values
• Together with safety physician manages leads the authoring for aggregate safety reports (e.g. PSUR, DSUR, Line listings) in close collaboration with the cross functional lead and operational functions
• Supports all SRMT preparation and documentation with guidance from mentor and safety physician
• 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
• 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.
• Identifies gaps in overall processes and initiates change as appropriate.
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 $68-78.85/hr based on experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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