Senior Manager, Postmarketing Pharmacovigilance
Position Responsibilities:
- Ensure Postmarketing reporting process is efficient and compliant with reporting requirements and as detailed in the Safety Management Plan.
- Collaborate within pharmacovigilance team on work activities regarding safety signals, analysis and safety data summaries. Assist with data collection for safety inquiry responses
- Assist with data collection for development of safety content for relevant safety documents or sections.
- Review safety database data listings, as assigned, for inconsistencies and summarize draft queries as appropriate
- Review relevant study documents for safety-related information for assigned projects (e.g., registry protocols, Safety Management Plan, SAE Reconciliation Plan, etc.)
- Support review of postmarketing data for SRT review
- Coordinate scheduling of SRT, including collation and distribution of meeting materials and setting of agenda
- Support aggregate report deliverables
- Assist with data collection as needed to support labeling activities
- Assist with oversight of pharmacovigilance vendor activities including but not limited to assessment, evaluation, tracking and reconciliation of safety information
- Oversee monthly reconciliation process performed by PV vendor
- Support team review of regulatory safety documents for assigned projects, e.g., Periodic Risk Benefit Evaluation
- Reports (PBRERs), Periodic Adverse Drug Evaluation Report (PADER) and Risk Management Plan(s) (RMPs)
- Review ICSRs (including case narratives, causality assessments and coding) for assigned projects
- Interface with outside partners and vendors for clinical pharmacovigilance around patient safety related tasks. Liaise with PV vendor to coordinate updates to relevant plans
- Assist with other PV compliance activities as required. Create and/or maintain relevant departmental documents such as expectedness list and coding conventions
- Perform additional tasks as instructed
- Bachelor’s degree in relevant scientific discipline. Clinical experience (e.g. RN, BSN, or PharmD) is preferred, but not required
- Drug Safety professional with minimum 6 to 8 years of direct experience within drug safety and PV, inclusive of case quality control and regulatory submissions of ICSRs worldwide
- Ability to interpret health and medical records such as adverse event reporting forms, discharge summary, etc.
- Experience with safety databases; Argus is a plus but not mandatory
- Good knowledge of pharmacovigilance reporting rules and timelines
- Good knowledge of ICH E2B(R2) and (R3) specifications and entry guidance
- Experience with clinical case processing, including MedDRA and WHO Drug coding and narrative writing
- Experience in managing external teams preferred
- Excellent in detailed-oriented tasks
- Excellent written and verbal communication skills
Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.
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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