Manager, Pharmacovigilance

Job Description Summary:
**Job Description**:
Location: Sao Paulo (Brazil)

Overview

Founded in 1998, PTC Therapeutics is a global commercial, diversified biopharmaceutical company. Our team is deeply committed to a unifying purpose: Extending life’s moments for rare disease patients and their loved ones.

PTC is a science-led, patient-centered biopharmaceutical company focused on discovering, developing and commercializing medicine for patients with orphan diseases.

PTC Therapeutics is proud to have been certified as a Great Place to Work in Brazil (2021) and recognized in 6th place among best multinational companies of 100 employees.

Visit our website to learn more about our company and culture

Site:
Under the oversight of the Brazilian QPPV, the Manager and Deputy Brazilian QPPV, fulfills the responsibilities associated with being a nominated pharmacovigilance (PV) contact to Regulatory agencies in Brazil and South America where required and appropriate.

More specifically, the Manager PV LATAM is a key contributor for oversight of the pharmacovigilance system for all of PTC’s medicinal products in Brazil. This includes, but may not be limited to, ensuring that PTC has an appropriate pharmacovigilance system in place, performing PV submissions, conducting review(s) of the safety profile for marketed products and acting as the point of contact with the appropriate regulatory/competent authorities as required and appropriate.

The Manager PV LATAM will fulfil the role of Deputy QPPV in Brazil and nominated deputy safety contact in other countries where required in LATAM.

Working with the Brazilian QPPV, they will provide oversight for the quality and standards of the PV function in LATAM in order to ensure full compliance with LATAM PV regulations.

The incumbent works cross-functionally with internal departments and external resources on PV-related issues.

The Manager PV LATAM also supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

ESSENTIAL FUNCTIONS- Fulfills all regulated responsibilities of the Brazilian Deputy Qualified Person for Pharmacovigilance.- Acts as a backup when Brazilian QPPV is out of office as the single PV contact point for the LATAM regulatory authorities and is also as a contact point for PV inspections.- Supports the Brazilian QPPV with LATAM PV documents (LATAM addendums to Risk Management Plans (RMPs) and periodic reports etc.,.) through authoring, review, and delivery in a timely manner.- Supports all LATAM PV contacts by maintaining an open line of communication and through regular meetings and communications.- Key contributor to the company’s adherence to the PV quality system, SOPs and processes. Ensures compliance with PV-related regulations within the region.- Maintains awareness of any conditions or obligations adopted as part of the marketing authorizations and other commitments relating to safety or the safe use of the products and maintains awareness of risk minimization measures.- Performs submission of expedited ICSRs and safety reports to concerned local health authorities (where applicable).- Ensures quality, including the correctness and completeness of PV data submitted to the competent authorities in Brazil (ANVISA).- Provides input into the preparation of regulatory action in response to emerging safety concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals).- Working with Head of PV Operations and with Brazilian QPPV, contributes to local Safety Data Exchange Agreements (SDEAs) and/or PV agreements with PTC partners and/or vendors for LATAM specific obligations for safety data exchange and reporting.- Builds relationships, and collaborates with, the Quality department to ensure appropriate processes are in place for inspection readiness. This includes, but may not be limited to, leading pharmacovigilance audit responses, developing and managing corrective action plans, etc.- Contributes to inspection readiness and and supports the Brazilian QPPV with LATAM Authority inspections of PTC’s PV function.- Participates in process improvement and vendor-client Safety Management Plans and timelines processing and reporting safety data from clinical trials and post-marketing surveillance within the LATAM region.- Trains PTC stakeholders on LATAM PV regulations and requirements as required.- Performs other tasks and assignments as needed and specified by management.

**REQUIREMENTS**:
- Science, Nursing or Pharmacy degree required-
- Solid pharmacovigilance experience in a pharmaceutical, biotechnology or related environment with experience as a Deputy QPPV.-
- Fluent in Portuguese, Spanish and English-
- Good knowledge of LATAM PV regulations and International Conference on Harmonisation (ICH) guidelines, initiatives, and regulations governing pharmacovigilance.-
- Experience in writing SOPs and developing processes.-
- Experience