Stark Pharma Solutions Inc
Pharmacovigilance Scientist
Stark Pharma Solutions Inc, Oklahoma City, Oklahoma, United States
Overview
We\'re seeking an experienced
Pharmacovigilance Scientist
to lead safety surveillance and risk management activities for both investigational and marketed products. This role is key to ensuring the integrity and accuracy of safety data, working closely with the Safety Physician/Medical Monitor and cross-functional teams to meet global pharmacovigilance requirements. Key Responsibilities
Lead and manage ongoing safety surveillance, signal validation, and aggregate reporting (PSUR, PADER, DSUR) Conduct literature reviews and prepare materials for safety governance meetings Handle ad hoc safety queries and regulatory authority requests Support clinical development activities, including IB updates, DSMB presentations, CRF/ICF development, and safety narratives Ensure compliance with evolving global pharmacovigilance regulations, SOPs, and internal quality standards Required Qualifications
Minimum 3+ years of experience as a Pharmacovigilance Scientist Minimum 5+ years in pharmaceutical, medical, or clinical research roles Advanced degree preferred: PharmD, RN, MD, PhD, MPH, or NP Strong analytical and writing skills with proficiency in Excel Background in mental health or neurology therapeutic areas Preferred / Bonus Skills
Familiarity with MedDRA, Argus Safety, and safety database systems Strong project management, communication, and leadership skills Ability to work both independently and collaboratively within multidisciplinary teams
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We\'re seeking an experienced
Pharmacovigilance Scientist
to lead safety surveillance and risk management activities for both investigational and marketed products. This role is key to ensuring the integrity and accuracy of safety data, working closely with the Safety Physician/Medical Monitor and cross-functional teams to meet global pharmacovigilance requirements. Key Responsibilities
Lead and manage ongoing safety surveillance, signal validation, and aggregate reporting (PSUR, PADER, DSUR) Conduct literature reviews and prepare materials for safety governance meetings Handle ad hoc safety queries and regulatory authority requests Support clinical development activities, including IB updates, DSMB presentations, CRF/ICF development, and safety narratives Ensure compliance with evolving global pharmacovigilance regulations, SOPs, and internal quality standards Required Qualifications
Minimum 3+ years of experience as a Pharmacovigilance Scientist Minimum 5+ years in pharmaceutical, medical, or clinical research roles Advanced degree preferred: PharmD, RN, MD, PhD, MPH, or NP Strong analytical and writing skills with proficiency in Excel Background in mental health or neurology therapeutic areas Preferred / Bonus Skills
Familiarity with MedDRA, Argus Safety, and safety database systems Strong project management, communication, and leadership skills Ability to work both independently and collaboratively within multidisciplinary teams
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