Pharmacovigilance Manager – Benefit Risk

Position Summary

The Pharmacovigilance (PV) Manager – Benefit Risk is a senior safety professional responsible for leading and overseeing benefit-risk evaluation activities across assigned products and client portfolios. This role ensures the continuous assessment of product safety profiles through structured signal evaluation, safety data analysis, and integrated benefit-risk assessments in compliance with global regulatory requirements, including ICH E2E, ICH E2C(R2), EMA GVP Modules V and IX, and FDA guidance.

The PV Manager – Benefit Risk acts as a subject matter expert in benefit-risk methodology, collaborating cross-functionally with signal management, aggregate reporting, medical review, clinical, and regulatory teams to support proactive safety surveillance and informed decision-making throughout the product lifecycle.

Essential Functions

• Lead and oversee benefit-risk assessments for assigned products, ensuring a proactive and continuous evaluation of safety and efficacy data.
• Author and review benefit-risk sections for aggregate reports (PSURs/PBRERs, DSURs, PADERs), risk management plans (RMPs), and other regulatory documents.
• Collaborate closely with Signal Management teams to evaluate and contextualize safety signals within the overall benefit-risk profile.
• Perform structured benefit-risk evaluations using qualitative and quantitative methodologies (e.g., BRAT framework, weighted analyses, or similar approaches).
• Integrate data from multiple sources, including clinical trials, post-marketing surveillance, literature, and real-world evidence, into comprehensive benefit-risk evaluations.
• Support safety governance activities, including preparation of Safety Management Team (SMT) or Safety Review Committee (SRC) materials.
• Provide strategic input into risk minimization measures and risk management strategies, including RMP development and updates.
• Ensure alignment of benefit-risk conclusions across regulatory documents and submissions.
• Review safety data outputs (line listings, summary tabulations, signal reports) to support benefit-risk decision-making.
• Act as a key point of contact for clients and internal stakeholders on benefit-risk topics and safety strategy.
• Lead, supervise, and mentor PV Specialists and Senior PV staff contributing to benefit-risk and signal evaluation activities.
• Contribute to the development and continuous improvement of SOPs, work instructions, and templates related to benefit-risk evaluation.
• Maintain current knowledge of global pharmacovigilance regulations, methodologies, and evolving best practices in benefit-risk assessment.
• Support audits and inspections, ensuring readiness and appropriate documentation of benefit-risk decisions and processes.
• Ensure compliance with all applicable guidelines, policies, legal, regulatory, and compliance requirements.

Education

Advanced degree in life sciences, pharmacy (PharmD), or medicine (MD) preferred. Additional qualifications in pharmacoepidemiology, biostatistics, or regulatory affairs are an advantage. Experience Minimum 5 years of pharmacovigilance experience, with at least 2–3 years focused on signal management and/or benefit-risk evaluation.

Demonstrated experience in authoring or contributing to benefit-risk sections of aggregate reports (PSUR/PBRER required).

Experience with RMP development and signal evaluation processes strongly preferred.

Experience working within a CRO, PV vendor, or pharmaceutical company in a global environment.

Computer Skills

Safety databases (e.g., Oracle Argus Safety, ArisGlobal LifeSphere, Veeva Safety, AB Cube SafetyEasy).

Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).

Literature databases (e.g., Embase, PubMed).

Familiarity with signal detection tools (e.g., Empirica, PV Analytics tools) and data visualization platforms is an advantage.

Competency Statements

Analytical Thinking – Ability to interpret complex datasets and translate them into meaningful benefit-risk insights.

Critical Thinking - Ability to evaluate multiple sources of information and make sound, evidence-based decisions.

Attention to Detail – Ensures accuracy and consistency across safety evaluations and documentation. Leadership – Ability to guide, mentor, and support team members in benefit-risk activities. Communication, Written – Ability to clearly articulate complex benefit-risk concepts in regulatory documents. Communication,

Oral – Ability to effectively present safety assessments to stakeholders and clients. Problem Solving – Ability to proactively identify and resolve safety-related issues. Collaboration – Ability to work effectively across cross-functional teams.

Customer Oriented – Ability to understand and meet client needs while maintaining compliance. Technical Aptitude – Strong understanding of pharmacovigilance regulations and benefit-risk methodologies.

Accountability – Takes ownership of deliverables and ensures timely completion.

Adaptability – Ability to adjust to evolving regulatory requirements and client expectations.

Work Environment

Remote: Romania / Poland or Portugal

The company has reviewed this job description to ensure that essential functions and basic duties have been included. It is intended to provide guidelines for job expectations and the employee's ability to perform the position described. It is not intended to be construed as an exhaustive list of all functions, responsibilities, skills, and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate. This document does not represent a contract of employment, and the company reserves the right to change this job description and/or assign tasks for the employee to perform, as the company may deem appropriate.

To apply for this role:

Step 1: Proceed to follow the form instructions

Step 2: Our HR team will review your application with feedback

Step 3: If successful, HR will arrange your Introductory call

Step 4: A potential online language assessment

Step 5: 1st formal interview

Step 6: 2nd formal interview

Step 7: Offer

NB* To be fully informed, the Job Description will be provided at Step 3 along with further information so that all aspects of the role are covered as much as possible.

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