Pharmacovigilance Specialist - MSD

Job Description

This is a temporary role for a 9-month duration. As the Pharmacovigilance (PV) Specialist, you will be responsible for specified PV activities (as delegated/assigned by your manager) and can perform these tasks with minimal supervision.

You will also be responsible for ensuring adherence to all applicable regulations, company policies and procedures. The items listed below are activities that can be performed by the role as assigned by the manager and apply to all supported countries.

Responsibilities:

• Responsible for execution of local PV processes and activities in collaboration with applicable internal functional areas and external parties, ensuring alignment with local legislation and local/regional/global company procedures and policies. Activities may include, but are not limited to, management and negotiation of local PV agreements, local due diligence activities, Post approval Safety Monitoring Program (PSMP) implementation, scheduling and coordinating aggregate safety report submissions, conducting local training, review of local initiatives for compliance with PV requirements, and communication of safety issues.
• Responsible for the execution of local PV processes and activities in collaboration with internal functional areas and external parties as assigned.
• Responsible for day-to-day adverse events case management, which may include case intake, translations (English and/or local language (as applicable)), acknowledgements, follow-up and submission activities by PV procedures and country regulations.
• Supports local PV, business partner and vendor audits and inspections, including readiness activities, document requests and CAPA activities.
• Participates in issue management/compliance activities and coordinates / prepares the necessary local corrective actions.
• Supports development and maintenance of local PV procedures and controlled documents in compliance with local, regional and global standards, to ensure global quality PV data.
• Supports PV self-inspections as required by PV legislation (where applicable).
• May be assigned responsibility for ensuring appropriate implementation and oversight of Risk Minimisation Measures and Additional Risk Minimisation Measures locally as per department policy and local legislation.
• Prepare/maintain/submit local RMPs to the local HA (as applicable).
• May be responsible for managing and performing local literature screening and assessment by company procedure and local requirements (as applicable).
• Support local implementation of applicable business continuity plans
• Responsible for filing, storage and archiving of safety-related documentation by company policies and local requirements.
• Serves as local Subject Matter Expert on relevant PV regulations, processes, and procedures. 
• Translates or QC's translation of applicable PV documents.
• Supports PV Lead in maintaining the local PV Training matrix and onboarding plans.
• May be responsible for reviewing, providing input and approving local initiatives (e.g., digital interfaces, marketing initiatives/ patient programs, organised data collection systems, etc.), and other programs to ensure compliance with PV requirements, as applicable
• May be responsible for Health Authority Website Monitoring for potential safety issues, safety alerts, and new/revised PV requirements in compliance with company procedures and local legislation (as applicable).
• Liaises with the local business units to keep them apprised of safety activities and provides input on strategic decisions.
• Represents PV in cross-functional organisational and alliance partner forums as needed.
• Participates in local company committees and councils for matters impacting PV as assigned. 21. Participates in special projects or rotational assignments within or outside of IPV as part of their professional development.
• Responsible for completing all required/applicable trainings assigned at the time of hire and after hire, by the due dates and before performing the activity.

Education:

• Health, life science, or medical science degree or equivalent by education/experience

Work Experience:

• At least 1 year of PV experience in the pharmaceutical industry is preferred.
• General knowledge of AE reporting requirements and relevant PV regulations

Job-specific competencies & skills:

• Must be fluent in English (written and spoken) while proficient in the local language.
• Demonstrates proficiency in communication, organisational, and time management skills.
• Ability to work in partnership with others (internally and externally).
• Ability to interface broadly?with colleagues within related functions and cross-functionally, and be able to work independently with no supervision except in the most complex of situations.?
• Demonstrates skills to drive change that enhances processes within the company or cross-functionally that improve quality and /or add value to the business.