Sr Pharmacovigilance Specialist

Opportunity

The Sr Pharmacovigilance Specialist supports the Drug Safety / Pharmacovigilance Department in providing drug safety expertise and leadership to assure that the company meets its business objectives of

compliance with pharmacovigilance regulations. The position provides PV support to both approved products

and products under investigational applications. The following tasks fall under Sr Pharmacovigilance Specialist

Key Responsibilities

• Ensures ICSRs/SUSARs case management is done in alignment with the applicable reporting timelines and pertinent requirements, by overseeing the activities executed by the involved PV-Contract Service Provider (PV-CSP) in alignment with the applicable Safety Management Plan and SDEA/PV Agreement. May include the need for case processing activities including but not limited to: Triage, Data Entry, Assessment, Quality Review, query generation, manufacturer notifications and coding. Tasks may include review of source information, MedDRA coding, narrative preparation, preliminary seriousness, causality / listedness assessments, case corrections and listing reviews.
• Supports the management and oversight of Case Management Mailboxes and other sources of intake for ICSR processing.
• Supports the management PVAs and implementation of PV agreements/contracts
• Collaborates with PV-QA for the management of deviations and related investigation and CAPA identification, PV quality audits (e.g. internal and vendor audits), elaborations and reviews of procedures and in the management of controlled changes impacting on safety processes.
• Supports the inspection readiness of the activities executed and, whenever necessary, support the inspection management providing the required documentation, performing quality checks, contacting PV-CSP as needed, and being part of the Inspection team or acting as SME.
• Vendor oversight / Point person for interactions with the vendor(s) for PV Operations

o Management and oversight of PV vendor(s) with regards to intake and reconciliation activities

o Support PV management in the oversight of vendor supported ICSR intake/processing

o Monitor performance metrics of the Vendor

o Provide feedback to the internal team and Supervisor

• Oversees the activities performed by delegated PV Operations PV-CSP by:

o Overseeing the ICSR/SUSARs intake, processing, submission, and reconciliation activities.

o Support PV management by monitoring the performance metrics of the PV-CSP.

o attending the operational meeting periodically executed together with the PV-CSP providing feedback to the internal team and Supervisor.

o Ensuring PV-CSP is trained as required.

o Assisting the generation of database queries for AE listings

• Serves as PV SME for associated project / product related meetings / committees.
• Ensures the maintenance of all PV records managed as per company SOPs.
• Performs assigned PV related activities in accordance with SOPs and regulatory requirements.
• Supports guidance document development and updates including but not limited to SMPs, SOPs, other guidance / training documents.
• Supports development / update of tools utilized by PV to ensure compliance and other tasks.

Qualifications

• Minimum of 6+ years of direct pharmacovigilance experience
• Experience with safety databases (i.e., ARGUS, ARISg or other safety database applications), electronic data capture (EDC) systems, and electronic document management systems.
• Knowledge of GVP, GCPs, ICH guidelines and FDA, EMA, and other international regulations and guidelines
• Working knowledge of MedDRA and WHO Drug dictionaries
• Experience with onboarding, overseeing, and managing safety vendors.
• ICSR submission experience is highly preferred.
• Strong interpersonal and communication skills; proactive approach. Able to work both independently and in a team environment.
• Detail-oriented, with good organizational, prioritization, and time management proficiencies. Must be able to work on multiple projects simultaneously.
• Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures.
• Proficient in standard computer software (Word, Excel and Power point presentations)
• Previous experience and formal training with safety database programs including configuration and validation activities is desired.

Education

• Bachelors / Advanced degree preferably in life science, nursing, pharmacy or other healthcare related profession (RN, PharmD, NP, PhD, MPH, etc.)

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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