Pharmacovigilance Specialist - Contract

Title: Pharmacovigilance Specialist
Location: 100% Remote
Duration: 12+ Months

Summary:
Provides operational support for global pharmacovigilance activities of Clients marketed products. Ensures pharmacovigilance deliverables are of the highest quality and meet global regulatory reporting timelines. Responsible for data review, compilation, and analysis, including management of the integrated safety database.

Primary responsibilities for the role:

Management of Adverse Events including activities such as processing adverse event case reports and conducts follow-up
. Notifies regulatory agencies and business partners accordingly; responds to requests from regulatory agencies
. Reviews scientific literature and bibliographic sources; draft and manage periodic safety update reports.
. Evaluates safety profiles; draft and manage signal detection reports; ensures document filing and archiving.
. Participation in the processes of involving the collection, processing, review and distribution of adverse event information
regarding development and marketed Client's pharmaceutical products.
. Contributes to ensure compliance of pharmacovigilance activities including activities such as conduct case reconciliation with
concerned departments, affiliates, distributors or business partners
. Take part in self-inspection visits, audits, inspections and in CAPAs management, create or update pharmacovigilance procedures
and working practices
. Provide training to concerned persons based on the training plan and managing training documentation; archive documents
according to prevailing standards
. Support in the procedures of global pharmacovigilance operations such as Standard Operation Procedures (SOPs), internal
business practices or working instructions.
. Serves in an advisory capacity including activities such as product monographs review, draft responses to pharmacovigilance
requests from regulatory agencies; participates in the drafting and implementation of pharmacovigilance contracts and
agreements.

Be sure to see notes before submitting candidates

The following questions must be asked, and the answers shared at the top of submitted resumes:
1. List specific areas of expertise in Pharmacovigilance you have focused on.
2. What safety database(s) have you used, and what types of cases have you processed? Those without may be rejected.

This position is for Adverse event monitoring. This person will deal with marketed products and side effects, follow up with reporters (patients, Doctors, etc.), and triage case reports. Looking for someone with a background in Pharmacovigilance who can follow international regulatory guidelines. Preference is for the ARGUS database. PSUR exp would be nice. The interview will consist of a phone screen with the local manager and a second phone screen with management in Barcelona. The team is based in LA, but it is a global team and will need someone who can be flexible in scheduling meetings across multiple time zones. This Role is remote