Sr Pharmacovigilance Associate III

Essential Functions Of The Job

• Support GPS procedural document management activities including the creation, review, and revisions of controlled documents, policies and procedures.
• Support the maintenance of the Global PSMF, local PSMFs and annexes on a regular basis to ensure that content accurately reflects the company's PV processes and compliance with regulatory requirements in an expedited manner.
• Ensures high service level to GPS stakeholders by advising on document strategy for GPS teams and supports content development for specific procedures across multidisciplined teams.
  
  

GPS Document Standards

• Leads the development of procedural documents across multidisciplinary teams, ensuring appropriate input from cross-functional GPS groups and relevant business functions.
• Supports the end-to-end Document Change Control process.
• Collaborates closely with GPS management, subject matter experts, and other functions to develop and revise SOPs and procedural documents, ensuring all relevant stakeholders are engaged.
• Identifies, supports resolution of, and escalates issues related to procedural documents as needed.
• Demonstrates strong document writing skills, with the ability to create, update, and refine process steps, descriptions, and responsibilities in line with document standards.
• Drives global harmonization of procedural documents to ensure clarity, consistency, and alignment with the company documentation hierarchy and conventions.
• Proficient in Veeva QualityDocs.
• Possesses strong knowledge of pharmacovigilance (PV) processes.
  
  

PSMF Responsibilities

• Support the end-to-end management of Global and/or Local PSMFs, including data collection, timely receipt of data and supporting documentation for quality control, Veeva workflow management, query resolution and follow-up, logbook generation, and PSMF formatting and publishing.
• Support the review of PSMF data and ensuring the application of internal core PSMF strategy, to ensure correct data inclusion
• Support the conduct of timely quality control checks for each PSMF contribution, including but not limited to PSMF Narrow Reviews and PSMF Consistency Checks for Global and Local PSMF.
• Participating and supporting in Audits and Inspections as a PSMF SME.
• Maintains oversight of local PSMFs and variations and deviation to the Core PSMF due to local regulations.
  
  

Education Requirement: Bachelor's Degree (no preference on type of bach)

Experience

• Five years or more of experience in pharmacovigilance in operational roles, has a deep understanding of pharmacovigilance and regulatory requirements & processes.
• Minimum three years of experience of PV quality management, standards and PSMF maintenance.
• Demonstrated experience with implementing cross-functional partnerships and business processes.
• Strong command of global pharmacovigilance requirements.
  
  

Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.

Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.

Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.

Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.

Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.

Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.

Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.