Associate Director Pharmacovigilance - Brazil
Summary of Position
The Associate Director Pharmacovigilance reports to the Pharmacovigilance Country Lead (Director Level) . The Associate Director Pharmacovigilance manages direct reports within the PV team, is able to fully back-up the PV Country Lead and works alongside the PV lead to share managerial level tasks within the team.
The Associate Director Pharmacovigilace is responsible to organize Adverse experience case management responsibilities including HA submissions; aggregate safety report health authority submissions and health authority submission compliance for individual case safety reports and aggregate safety reports as well as being able to perform the tasks independently when required.
The Associate Director Pharmacovigilance is responsible for other activities (as delegated by the PV Country Lead) which may include but are not limited to: managing local contractual PV agreements, local due diligence activities, country level audits and inspection readiness activities and participation in audits and inspections, local initiatives, LCEs, PASS and PMAS, country SOPs, communication of safety issues, staff, training (for PV staff, non-PV staff, partners, vendors), people development, and special projects as required, and is able to work on these delegated activities independently.
In the absence of the PV Country Lead, the Associate Director PV is responsible for managing all day-to-day activies of the Pv department.
Major Activities and Responsibilities
(PV Country Lead will amend/delete the lists below according to the actual activities assigned. It is not an expectation or requirement that the Associate Director Pharmacivigilance undertakes all the activities / responsibilities listed)
Serves as the local Deputy Qualified Person for PV (QPPV)/deputy local responsible PV person for the countr(ies), Serves as the back-up to the PV Country Lead both in absence and presence (as required) of the PV Country Lead.
Responsible for overseeing all processes and procedures related to the day-to-day adverse experience case management within the country(ies) covered by the country operation including case intake and follow-up activities, HA submissions, aggregate safty report management in compliance with PV processes and regulations and MSD policies and procedures
Responsible to establish and coordinate reconciliation processes of adverse events reports received from other MSD operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners, as applicable.
Responsible to coordinate the filing, storage and archiving of safety-related data in accordance with MSD’s policies and local requirements.
Participates in individual case safety report compliance activities and coordinate the necessary corrective actions locally for the late reporting within the country(ies) covered by the country operation.
Prepares for audits/inspections for their country/territories, actively participates in the audit and/or inspection, provides recommendations of corrective and preventive actions (CAPA) and track CAPA commitments until closure.
Participates in and supports audits of contractual partners/vendors as necessary.
Defines and develops local standards and procedures (in compliance with regional and global standards) for the department, to ensure quality PV data and evaluates processes (also interdepartemental) for potential improvement in efficiency and effectiveness.
Drives implementation of PV standards across other areas with input to the PV system with the aim to ensure ‘always ready’ state for audits and inspections.
Directs development and maintenance of local PV controlled documents ensuring that they are kept up-to-date (i.e. local SOPs, training material etc.).
Proactively identifies procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders.
Leads the training of PV staff (including maintenance of the local PV training matrix and onboarding plans) and customer facing non-PV staff (e.g., Sales Reps, Medical Information, etc.) and distributors / vendors / business partners in the country(ies) within scope, including training documentation.
Provides expertise in the planning, execution, and maintenance of major projects.
Represents PV in cross-functional organizational and alliance partner forums as needed
Serves as internal Subject Matter Expert on relevant PV regulations, processes and procedures.
As delegated by the County PV Lead, is responsible for reviewing and approving local initiatives (e.g websites, registries, marketing intitiatives), local clinical evaluations, market research, post marketing active surveillance (PMAS), patient support programs (PSPs) and post authorization safety studies (PASS) protocols for compliance with PV requirements, as applicable.
Manage direct reports, as applicable:
Sets up priorities, organizes, oversees and monitors direct report’s activities, towards division’s and country’s objectives in compliance with policies and standards.
Ensures that direct reports are trained for their proper use of internal PV systems.
Ensures that staff is updated on new legislation and external or internal requirements on PV.
Provides direction, leadership and learning opportunities to enhance the development of direct reports.
Complete and document required PV training within the required timelines.
Liaise with internal stakeholders and colleagues on a local, regional or global level to ensure a functioning PV system on a local level.
Perform other activities as requested by the PV Country Lead, incuding representing the company at external safety/industry forum meetings.
In the absence of the PV Country Lead:
Serve as the point of contact for and communicates with the local Health Authority and/or liaises with Global Regulatory Affairs (GRA) / Global Medical Affairs (GMA) colleagues for questions from the Health Authorities regarding safety and ICSRs in the absence of the PV Country Lead.
Liaise with the country heads of Global Clinical Trial Operations (GCTO), Global Regulatory Affairs (GRA), Global Medical Affairs (GMA) and other business units to keep them apprised of safety activities and provide input on strategic decisions (i.e., new clinical trials, product launches, etc.).
Participate on corporate sponsored committees and councils (i.e. Medical Governance Council). As a member of the Medical Governance Council, represent Global Safety on matters / activities that impact or involve PV, thereby ensuring that the requirements in Global Safety procedures and the relevant Corporate Policies are met.
The incumbent must have a health, life science, or medical science degree or equivalent by education / experience and should have pharmacovigilance experience including oversight of quality, compliance and training, knowledge of PV systems/databases. Experience from participation in internal audits and inspections is preferred.. He/she must have in-depth knowledge of Pharmacovigilance regulations within his/her assigned country(ies), and be an expert in PV processes/activities. The Associate Director PV is expected to have excellent communication and time management skills, to have the ability to interface broadly with colleagues within related functions or cross-functionally and work independently with no supervision required except in the most complex of situations.
Broad knowledge of pharmacovigilance systems & requirements
In-depth understanding of pharmacovigilance principles, concepts, practices & standards
In-depth knowledge of the local country(ies) pharmacovigilance regulations & obligations
Knowledge of Good Clinical Practice concepts
Knowledge of local industry code(s) of practice
Understanding of risk management
: Drug/Dvcs Sfty Survnce (NonMD) Job Title:Assoc. Dir, Drug Safety
Local principal: LATAM-Brasil-SP-São Paulo
Status do funcionário: Regular
Número de vagas: 1
Company Trade Name:MSD