Sr. Pharmacovigilance Specialist

SUMMARY OF POSITION

The primary responsibility of the Senior (Sr.) Pharmacovigilance (PV) Specialist is to collect, accurately document, assess, code and process adverse event reports related to the marketed products monitored by the Par Health PV within the time frames established by Par Health PV and in compliance with global regulatory requirements as well as Safety Data Exchange Agreements. In this role, the Sr.

PV Specialist will serve as a primary contact point and recipient for adverse events. The Sr. PV Specialist will also manage processing and reporting of serious adverse events received during Company-sponsored clinical trials. The Sr. PV Specialist will either perform all of the pharmacovigilance activities as described or be involved in oversight of any PV Vendor/contracted research organization (CRO) handling pharmacovigilance activities on behalf of Par Health.

The Sr. PV Specialist is also responsible for handling related safety inquiries for internal and external customers and will be involved in analyses of safety data for Par Health pharmaceutical products. The Sr. PV Specialist will establish and maintain positive and mutually rewarding relationships with all company personnel involved in PV globally and domestically to ensure global PV compliance. The Sr.

PV Specialist will be involved in other tasks for Par Health as needed and will be cross trained to handle other functions as deemed necessary.

NOTE:

The Sr PV Specialist will either perform the essential functions or will be involved in the oversight of the functions if handled by a PV vendor/contract research organization.

• Collect and accurately document adverse event reports.
• Triage incoming adverse event information for completeness, consistency and seriousness, which includes medical evaluation and assessment.
• Process adverse events in the Par Health Safety System ensuring accuracy of event coding, event assessment, medical history and laboratory data as well as composing the written narrative.
• Review individual adverse event reports to ensure cases meet Par Health quality standards before approving for submission to regulatory bodies and safety partners.
• Prepare and submit expedited reports to regulatory authorities including obtaining the appropriate medical review.
• Effectively prioritize Par Health PV functions to ensure that all regulatory authority and safety partner timelines are satisfied.
• Review the results of all medical literature searches for any individual case safety reports or potentially relevant safety information and process as described in sections 4, 5, 6.
• Perform queries for adverse event reports as required (verbally, email, in writing).
• Ensure compliance with Safety Data Exchange Agreements involving safety partners.
• Execute searches in the Par Health Safety System as required.
• Integrate newly acquired pharmaceutical products into MNK Par Health PV system.
• Provide support during regulatory authority inspections, safety partner audits, internal audits, etc.
• Compile data for Aggregate Safety Reports as well as manage the process and timelines for developing the final Aggregate Safety Report to be provided to Regulatory Affairs or other appropriate department for submission.
• Distribute PV data and information to Quality, Legal, Regulatory Affairs or other departments as needed.
• Elevate potential safety signals and alert appropriate management personnel when needed.
• Initiate and coordinate investigations as necessary with Product Monitoring Department.
• Ensure proper adverse event handling, including reconciliation of events, by Par Health Product Monitoring and Medical Information Departments.
• Attend seminars to stay current with relevant global regulatory requirements and guidance regarding Pharmacovigilance and drug safety.
• Work in conjunction and effectively communicate with Product Monitoring, Medical Information, Regulatory Affairs, International Regulatory, Clinical Operations, Sales, Legal, Marketing, Quality Assurance and other department personnel.
• Participate in team activities concerned with the safety, development or support of products as necessary.