Senior Manager, Postmarketing Pharmacovigilance

Conshohocken, PA
Pharmacovigilance /
Full Time /
Hybrid
Position Summary:
 
Reporting to the Associate Director, Postmarketing Pharmacovigilance or higher, the Senior Manager, Postmarketing Pharmacovigilance will play a key role in supporting the safety assessment, evaluation, and risk management of products in the postmarketing setting, including involvement in safety surveillance activities.
 
Key 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
 
Qualifications and Skills Required:
 
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