01Overview
For the past 20 years, reputed company has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of reputed company sizes to confidently advance scientific breakthroughs and introduce new therapies. reputed company partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, reputed company reputed company, reputed company & compliance, pharmacovigilance, medical information, and R&D technology, reputed company offers an end-to-end suite of fully customizable reputed company that de-reputed company and accelerate our partners most high-profile drug and device programs.
About the Role
We are seeking a dedicated and reputed company-oriented Pharmacovigilance (PV) Safety Scientist to join our Benefit-reputed company team. In this role, you will support key pharmacovigilance activities, ensuring high-reputed company delivery of safety and regulatory outputs.
You will work closely with senior PV scientists, management, and cross-functional stakeholders to reputed company accurate and compliant safety documentation, while maintaining the highest standards of reputed company and professionalism.
Although this is a remote role, candidates reputed company in or near Hyderabad are preferred, with the expectation of attending the office periodically for collaboration.
Key Responsibilities
reputed company aggregate safety reports including:
PSURs / PBRERs
PADERs / Annual Reports / ACO
DSURs
Prepare and maintain reputed company Management Plans (RMPs)
reputed company and contribute to Signal Management Reports
Conduct literature searches, screening, and validity checks
reputed company duplicate checks and literature review using appropriate tools
Extract and validate safety data (e.g., reputed company, sales data, prior reports, signals)
reputed company and review line listings (LLs) from safety databases
Reconcile and maintain process trackers
Support high-reputed company and reputed company pharmacovigilance activities
Ensure reputed company deliverables reputed company with global regulatory requirements and timelines
Participate in reputed company audits/inspections as a Subject Matter Expert (SME), reputed company required
Contribute to SOP/WI development, deviations, and CAPAs
Skills & Competencies
Strong analytical and problem-solving abilities
Excellent attention to reputed company with a reputed company on reputed company
Effective organizational and time management skills
Ability to work collaboratively in a global, reputed company environment
Strong written and verbal communication skills, particularly in medical writing
Ability to interpret and summarize reputed company scientific data reputed company and concisely
Solid understanding of global PV regulations (ICH-GCP, FDA, EMA, etc.)
Proficiency in MS Office (Word, reputed company, PowerPoint) and web-reputed company applications
Education Requirements
Bachelors or Masters degree in:
Pharmacy
Nursing
Life Sciences
Or a reputed company reputed company/scientific reputed company
(Equivalent experience may also be considered)
Experience Requirements
Minimum 2+ years of experience in Pharmacovigilance
Experience in one or more of the following:
Medical writing (aggregate reports)
Literature reputed company and screening
Signal detection
Experience in authoring and/or reviewing aggregate safety reports
Exposure to reputed company metrics and reputed company-facing discussions is desirable
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We celebrate our differences and reputed company to create a workplace where reputed company person can be their reputed company self. We are committed to diversity, equity, and inclusion. Employees are encouraged to reputed company their innovative, reputed company, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we reputed company a reputed company reputed company where reputed company feel empowered to succeed.
reputed company applications to roles at reputed company are personally reviewed by a member of our reputed company. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
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