Local Medical Safety Specialist

Essential Job Duties and Responsibilities

Support activities related to safety reporting requirements as required by Marketing Authorization Holders (MAH) and/or study sponsor, as applicable.

Ensuring Individual Case Safety Report (ICSR) case processing and related activities are carried out to enable compliance with applicable regulatory requirements, company procedures, at a local/regional level or global level, and in compliance with provisions of PV agreements with business partners.

Ensure the pro-active Benefit Risk Management throughout product life cycle translating global safety data to insights and actions tailoring to local specificities and needs.

Handle the following tasks, independently and with minimal supervision;

Compliance Related activities

Aggregate reports

• Support LSO to undertake local review and ensure the tracking and submission applicable safety aggregate reports (PSURs/DSURs) if applicable.

PV-Safety training support

• Perform Pharmacovigilance training for Local Operating Company employees as applicable;

• Manage AE/PQC trainings to distributors/vendors and translation of AE/PQC material, where needed;

• Follow up for completion of global roll out AE/PQC training in LOC.

PV contract management

• Management of local PVAs and ensure local implementation, including LSU training and adherence to PVAs

• Function as LMS Lead reviewer to have PVA implementation and oversight

• Coordinate the provision of support for third party safety agreements locally e.g. local Vendor Agreements as necessary, seek support from central functions like PV Service and Technical Contracts Group and RRA CoE as necessary

• Provide and/or review quarterly listings for the PSMF Annex B (vendor agreements and commercial agreements) for agreements signed by local Opco and ensure accuracy and timeliness

• Support the LSO in taking responsibility for Products of Local Opportunity (POLOs) agreements, and support the implementation of the PV agreement locally, as appropriate.

Safety regulations

• Support LSO in review of new/revised PV regulations, evaluation of the impact on local processes and notification of appropriate global and regional as well as implementation of new legislation with local impact, as applicable.

Local Communications

• Work with the LSO and with Regulatory Affairs to forward any safety-related inquiry or relevant communication from the local RA to the appropriate global and regional groups (GMS Support Desk, GMS Physician, OCMS, QPPV Offices, VP PV & Medical Compliance) as appropriate. This may include local, regional and/or global expertise

• Support the LSO to provide safety-related regulatory communication (e.g., response to request for information from Local RA)

Supporting PV system oversight (PV and non-medicinal product safety)

• Provide insights into metrics to LSO, lead actions as needed, escalate non-conformances in a timely manner.

• Act as CAPA Content owner and subject matter expert, own actions as required - depending on topic

• Procedural Document review from SMEs and Area leads - depending on topic. Perform Impact assessments and action as required on local level - depending on topic

• Provide content for the LMS PSMF contributions and data, as required, on time and in high quality, ensure accuracy

Pharmacovigilance and Vigilance Service Provision

• Collaborate with LSO to ensure that day-to-day Pharmacovigilance activities and safety activities are performed satisfactorily, and that full regulatory compliance is maintained at Local Operating Company level including adequate record management, translation, follow up request, local literature review, submission to RA, as applicable.

• Collaborate with the local Marketing Authorization Holder (MAH) to enable fulfilment of its regulatory responsibilities (including Pharmacovigilance Agreement (PVA's)) and meet their business objectives

Inbound & Outbound ICSR Management

• Receipt, assessment and processing of incoming safety information from multiple sources, both internal and external to the Company.
• Enter relevant/required safety data into the Global Inbound Receipt System (GIRS) from spontaneous, clinical trials and other solicited sources.
• Provision of safety information/acknowledgements to marketing partners/other third-party partners/Global Medical Safety within the internal and contractual timelines.
• Data entry for complex cases
• Performing follow-up for requesting additional information from multiple sources.
• Assist in the quality review of data captured in the GIRS as applicable
• Verify and ensure translation of safety information, if applicable.
• Continual monitoring, assessing the reportability of ICSRs due for regulatory reporting, and submitting to respective Competent Authorities (CAs) / Business Partners (BPs), as applicable.
• Liaise with applicable stakeholders to support case processing requirements for Medical device vigilance, pharmacovigilance.

Audit/Inspection

• Represent the Local Safety Unit in matters pertaining to audit or inspection preparation or conduct.

Benefit Risk Management

• Establish Product knowledge with focus on safety profiles, Therapeutic Area and Disease Pathway knowledge supporting the needs of the local Medical and Marketing organization in collaboration with the International Medical Safety leader or MSO and the Local Safety Officer (LSO) if applicable

• Act as safety expert in cross-functional team meetings and perform training on safety relevant aspects, as appropriate;

• Provide Risk Management Plan status updates;

• Involvement in implementation of Risk Management Plans and Urgent Safety Restrictions, if required;

• Participate in meetings with relevant stakeholders for discussion and evaluation of topics related to benefit risk and product safety as required;

• Involvement in DHPCs management, submit and track DHPCs to RAs (Regulatory Authority)/HCPs (if performed by LMS);

• Provide input into safety sections of local protocols (including Clinical Trials, Non-Interventional Studies, Research Related Activities, Patient Support Programs etc.) to ensure appropriate safety reporting as required by regulations;

• Perform concept and protocol review related to data generation activities - clinical and post-authorization studies (for Pharma in RECAP) and Local Safety Monitoring Plan (SMP);

• Provide support to RRA CoE for local RRA;

• Medical/ pharmaceutical assessment of local individual cases when requested in partnership with global teams if applicable;

• Undertake appropriate actions such as site visits for special interest cases as requested by LSO;

Minimum Qualification

Essential Knowledge & Skills

• Scientific/ life-science background, medicinal knowledge required; proficiency in Medical terminology (local languages). Pharmaceutical Sciences degree preferred.
• Ability to manage multiple critical issues.
• Computer literate with basic knowledge of GMS database systems.
• Awareness of and familiarity with industry principles of drug development and pharmacology
• Proficiency in global and local SOPs
• Good verbal and written communication skills, fluency in Portuguese and English language required.
• Ability to prioritize and work to strict timelines daily
• Ability to negotiate and communicate with internal and external customers. Ability to establish and maintain open relationships within the organization and with authorities.
• Demonstrable knowledge of local PV requirements and of Global aspects of drug safety.

Experience

• Scientific study and experience in pharmaceutical regulations and R&D processes.
• Pharmaceutical industry experience including a PV responsibility role required. (2-3 years, preferred)