Vice President, Pharmacovigilance Medical Lead
The Vice President, Pharmacovigilance Medical Lead will provide executive leadership of global clinical and postmarketing safety strategy, apply analysis and interpretation of complex safety data for signal detection and initiation of safety risk management activities. The VP, Pharmacovigilance Medical Lead is accountable for the overall medical oversight and safety evaluation within Pharmacovigilance.
Strategically lead the Pharmacovigilance team for Clinical and Postmarketing PV including signal management, safety surveillance and risk management plans
Provide PV subject matter expertise on Project Teams and other cross-functional activities, including global teams
Set medical strategies for global safety team
Identify potential challenges, risks and roadblocks associated with the global medical strategy and lead team in developing solutions to address these, working with other departments as needed
Author medical-safety sections of aggregate safety reports (e.g. DSURs, PSURs, PADERs, PBRERs, etc.)
Conduct medical review of individual case safety reports (ICSRs)
Participate in preparation and maintenance of Reference Safety Information (RSI) and product labeling
Collaborate with key stakeholders including business partners in appropriate safety analyses and risk assessment and management strategies
Actively participate in professional organizations, academic or regulatory working teams on matters that impact pharmacovigilance
Perform additional tasks as directed by senior management
Qualifications and Skills Required:
Physician (MD/DO or equivalent) with pharmaceutical industry background and proven competence in PV
Minimum 10 years pharmaceutical (or related) industry experience
Minimum 5 years working directly as PV physician in Clinical and Postmarketing PV
Knowledge of global safety regulations and guidelines (CIOMS, FDA, EMA, ICH, etc.)
Experience reviewing cumulative safety data with ability to interpret, synthesize, communicate, and present complex clinical /pharmaceutical information
Experience in the preparation and authoring of pre- and post-approval aggregate safety reports
Thorough understanding of the drug development process and context applicable to safety surveillance activities
Excellent interpersonal and communication (written and oral), analytical and results oriented project management plans
Highly ethical with strong compliance record
Ability to manage others through change, demonstrating poise under pressure and motivational leadership
Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.
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