Sobre

• This role requires a transformative leader to elevate the Medical Affairs and Pharmacovigilance organization in LATAM, ensuring full regulatory compliance while enabling business growth through new products, customers, geographies, and processes.

• The role provides strategic and technical leadership in pharmacovigilance, medical affairs, and clinical studies, guiding teams to lead with science and pursue a patient-focused strategy that enhances access to treatments and ensures the highest standards of safety. It also develops budgets, policies, and procedures to strengthen the functional infrastructure and oversees critical systems in line with international, regional, and company regulations, standards, and procedures.

Key Responsibilities

Medical and Scientific support

• Leverage scientific expertise & customer insights to create a local patient centric Medical Affairs strategy per therapeutic area that is aligned with business strategic imperatives
• Provide medical and scientific support to marketing and business development
• Provide a deep understanding of pathophysiology and an in-depth product knowledge to facilitate discussion on a peer-to-peer level, in all disease areas with sound advice on treatment options to increase confidence in Acino's product portfolio and scientific credibility
• Execute on medical and product training for internal customers and external customers as required
• Facilitation of advisory board meetings, round table meetings, speaker briefing, roadshows, launch meetings and pre-launch activities etc
• Assist market access with scientific funder presentations to maximised reimbursement for Arcera products
• Support clinical trial (phase 4/post marketing surveillance) identification and planning including the review of the investigator proposals as required
• Liaise with Global medical partner's and Arcera GenMed global medical on a regular basis
• Provide a monthly medical report to line managers documenting scientific activities and present monthly report at cross functional team meetings

Medical Information

• Provide a medical information framework within LATAM region
• Bridge medical information and adverse event reporting gaps
• Provide clinical input and responses to complex product related and other medical queries by supporting the medical representatives in field receiving questions from clinicians and any other members of the public
• Ensure quality and timely turnaround time for medical information requests

Promotional Material

• Review promotional material where applicable, ensuring scientific correctness and interpretation of scientific reference articles used
• Ensure alignment with the marketing code authority
• Review training material

Pharmacovigilance

• Ensure knowledge of the pharmacovigilance standard of practice for all Arcera's marketed products
• Ensure complaint Pharmacovigilance and drug safety processes are in place, meeting the requirements of all relevant health authorities and partners
• Ensure monthly reconciliation for adverse events, with both Pharmacovigilance and Quality Assurance
• Assist with casualty assessments and off label reports to follow up with HCP’s
• Assist with internal Pharmacovigilance audits and ensure that Pharmacovigilance systems are up to date
• Forward all received Product Quality Complaints, Adverse Events and Medical Enquiries to the relevant person in Quality Assurance/ Pharmacovigilance/ Medical Affairs

External Networking and Collaboration

• Foster effective and open relationships with academia, External Experts, healthcare providers and government officials
• Lobby government bodies and non-governmental organizations in compliance with law.
• Ensure building the right advocacy and creating partnerships with HCPs/HCOs
• Provide support to Government Affairs Access strategy for different markets.
• Anticipate health care policies changes, propose local/regional strategy to address them and proactively communicate to relevant functions
• Reaches out & import new knowledge from outside the company
• Performs impact assessment of the new legislation

Global strategy support

• Support setting global medical and pharmacovigilance strategy with global MA/PV team.
• Clinical trials identification/preparation/execution and support in collaboration with relevant local, regional and global stakeholders.
• Gaining and providing relevant accurate insights to global functions
• Support global projects on local/regional and global levels.
• Involve global functions in the right level in regional projects when needed

General

• Member LATAM LT Team and member of Extended Leadership Team
• Member of RA/MA/PV Global Senior Leadership Team
• Serves as a thought leader in the understanding and application of evolving basic and translational science, regulatory science and public health to develop new approaches to improve the development, review and oversight of healthcare products
• Creates and implement crisis management plans and procedures.
• Manage medical and pharmacovigilance budget and other company resources
• Manage direct reports, including mentoring, coaching, training and development where needed
• Conduct annual and mid-term performance reviews with direct reports and lead Talent Audits
• Collaborate with the Global Medical Affairs in providing learning and development opportunities that meet high priority development needs among physicians within the regional Medical and Pharmacovigilance teams
• Ensure all SOP trainings are update to date and assist in SOP writing as required
• Ensure good documentation practices throughout the medical department
• Ensure compliance with regards to marketing code authority and internal compliance in terms of implementing Arcera's policies and procedures
• Ensure all training are to be completed as per training plan
• Collaborate with the cross functions to build effective and efficient working practices
• Promote a culture of innovation, constructive challenge, team spirit and accountability within the Medical and Pharmacovigilance teams that is based on ensuring the wellbeing of patients

Key Skills and Competencies

Knowledge and Skills

• Leadership capabilities with ability to identify and develop talents for current and future roles.
• Full understanding of legal/compliance environment and requirements.
• Full knowledge and understanding of the different health care systems/sectors in LATAM and international.
• Ability to learn about new technologies, strategies and policies, with high level of compliance with policies.
• Ability to create business relationships with internal and external customers and colleagues in different functions.

Competencies

• Strategic ability to manage complex stakeholder relationships and integrate diverse business interests.
• An original thinker with growth mindset with ability to lead effectively regional project teams and organization through complex challenges. An innovator who is able to inspire others.
• Has the ability to serve as thought leader in the understanding and application of evolving basic and translational science, regulatory science, and public health to develop new approaches to improve the development, review and oversight of healthcare products.
• Has the ability to serves as a thought leader in the understanding and application of compliance to develop new approaches to improve compliance performance and culture.
• Capable to identify and evaluate gaps in processes and procedures, assesses risks and elaborates on solutions, mitigation actions. Sets up processes needed.
• Ability to manage assigned budgets and resources effectively and maximize investments.
• Actively engages in talent management and engagement to cultivate a workforce that is well aligned with current and emerging talent needs.
• Continuously develops staff by making accurate assessments of individuals’ capabilities and performance, and providing feedback, coaching, guidance and mentoring.
• Demonstrates and proactively advocates working together in a spirit of openness, honesty and transparency that encourages engagement, collaboration, respectful interactions and trust.
• Communicates with knowledge, consistency, and clarity to maintain integrity and impact of the message.
• Excellent problem-solving, conflict management skills.

Qualifications & Experience

• A university degree in a relevant discipline M.D. (Pharmacy), MBA and Ph.D. is advantageous.
• Minimum 15 years of experience within pharmaceutical industry and 3-5 years in a similar position in Medical Affairs
• Regional Medical and Pharmacovigilance experience with development and commercialization of products;
• Experience in leading a successful team, ability to inspire and develop
• Excellent leadership skills, organizational capability and the ability to foster opportunities for talent development
• Strong change management skills and experience, to develop and drive an organization focused on excellence
• Proven experience of managing a team across several locations, and of working strategically with the corporate executives to contribute to the overall direction and performance of the company
• Excellent user of MS Office applications (Word, Excel, PowerPoint, Outlook)
• Experience with electronic systems and databases
• Fluent in English, both in oral and in writing