PV Specialist

Job Description

We are seeking aSpecialist PVto join our team in afull-time permanent position. The Specialist PV is responsible for specified pharmacovigilance (PV) activities as delegated and assigned by their manager and is expected to perform these tasks with minimal supervision. The role ensures adherence to all applicable regulations company policies and procedures.

In addition the Specialist PV may be designated by the PV Lead to serve as theBack-up (BU) Local Qualified Person for Pharmacovigilance (QPPV)/BU Local PV Contact/BU Local Responsible PV Person as required by local PV legislation. When designated and in the absence of the PV Lead the Specialist PV may manage day-to-day PV activities and act as back-up under supervision from a higher-level manager as required.

Key Responsibilities:

The responsibilities listed below may be assigned by the manager and apply to all supported countries. Additional local-specific responsibilities may be defined separately underAdditional Local Specific Activities.

Local PV Operations and Compliance

• Execute local PV processes and activities in collaboration with internal functional areas and external parties ensuring alignment with local legislation and 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

  • Reviewing local initiatives for PV compliance

  • Communicating safety issues

Case Management and Reporting

• Support day-to-day adverse event case management which may include:

  • Case intake

  • Translations (English and/or local language as applicable)

  • Acknowledgements

  • Follow-up activities

  • Submission activities in accordance with PV procedures and country regulations

Audit Inspection and Compliance Support

• Support local PV business partner and vendor audits and inspections including readiness activities document requests and CAPA activities.

• Participate in issue management and compliance activities and coordinate/prepare necessary local corrective actions.

• Support PV self-inspections as required by PV legislation where applicable.

Documentation Procedures and Training

• Support development and maintenance of local PV procedures and controlled documents in compliance with local regional and global standards to ensure global quality PV data.

• Responsible for filing storage and archiving of safety-related documentation in accordance with company policies and local requirements.

• Support the PV Lead in maintaining the local PV training matrix and onboarding plans.

• Complete all required and applicable trainings assigned at the time of hire and after hire by the due dates and before performing the activity.

Risk Management and Literature Activities

• May be assigned responsibility for ensuring appropriate implementation and oversight of Risk Minimization Measures and Additional Risk Minimization Measures locally in line with department policy and local legislation.

• Prepare maintain and submit local RMPs to the local Health Authority as applicable.

• May be responsible for managing and performing local literature screening and assessment in accordance with company procedure and local requirements as applicable.

Cross-Functional and Strategic Support

• Support local implementation of applicable business continuity plans.

• Serve as local Subject Matter Expert on relevant PV regulations processes and procedures.

• Translate or quality-check translations of applicable PV documents.

• May be responsible for reviewing providing input on and approving local initiatives such as digital interfaces marketing initiatives patient programs organized data collection systems and other programs to ensure PV compliance.

• May be responsible for Health Authority website monitoring for potential safety issues safety alerts and new or revised PV requirements in compliance with company procedures and local legislation.

• Liaise with local business units to keep them informed of safety activities and provide input on strategic decisions.

• Represent PV in cross-functional organizational and alliance partner forums as needed.

• Participate in local company committees and councils for matters impacting PV as assigned.

• Participate in special projects or rotational assignments within or outside of IPV as part of professional development.

Back-Up Responsibilities in PV Lead Absence

• Comply with all requirements set forth in local laws and regulations.

• Serve as the local subject matter expert on relevant PV regulations processes and procedures and ensure compliance.

• Act as point of contact for local Health Authorities and liaise with Regulatory Affairs Medical Affairs Clinical Research and other functional areas regarding PV questions.

• Perform procedural tasks of the PV Lead unless otherwise delegated.

• Report or escalate potential safety or security issues.

• Liaise with local business units to contribute to strategic decisions impacting PV.

Education:

• Degree in Health Life Science Medical Science or equivalent through education/experience at the hiring managers discretion.

Work Experience:

• At least 1 year of experience in the pharmaceutical industry is preferred at the hiring managers discretion.

• General knowledge of AE reporting requirements and relevant PV regulations is preferred but not required.

Skills and Competencies:

• Fluent in English both written and spoken with proficiency in the local language.

• Knowledge of Serbian language would be a very big plus.

• Strong communication organizational and time management skills.

• Ability to work in partnership with others both internally and externally.

• Ability to interface broadly with colleagues across related functions and work independently with minimal supervision except in the most complex situations.

• Demonstrated ability to drive change that improves processes enhances quality and/or adds value to the business.

What We Offer:

• Afull-time permanent position

• The opportunity to work in ahighly collaborative and international environment

• Broad exposure topharmacovigilance activitiesacross local regional and global levels

• Opportunities to build expertise inPV compliance safety operations and cross-functional collaboration

• The chance to contribute toprocess improvement quality enhancement and patient safety

• A supportive team environment with opportunities forprofessional developmentand participation in special projects or rotational assignments

Required Skills:

Preferred Skills:

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Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.

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