Senior Pharmacovigilance Specialist

Job Description

Senior PV Specialist Country Operations UK/IE

The Senior Specialist, PV is responsible for aggregate and individual case safety report (ICSR) health authority submissions and compliance monitoring (as needed). They are also responsible for PV activities (as delegated or assigned by their Manager) which may include but are not limited to:, management and negotiation of local PV agreements, local due diligence activities, participation in audits and inspections and related readiness activities,  review of local initiatives for compliance with PV requirements, SOP management, local training, communication of safety issues, people development, special projects as assigned and is able to work on these delegated activities independently.

We are seeking candidates with demonstrated experience in the above activities.

Education:

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

Work Experience:

• Experience in the pharmaceutical industry is preferred
• Experience with activities to be covered is preferred
• Strong leadership, communication, decision making, and problem-solving skills
• In-depth knowledge of relevant PV regulations, PV quality management systems and be an expert in PV processes and activities.
• Experience with PV audits and/or PV Health Authority Inspections

Job-specific competencies & skills:

• Must be fluent in English (written and spoken) while proficient in local language
• Ability to travel within the region and globally
• Demonstrates polished communication skills (verbal and written), adept at tailoring communication to different audiences and contexts.
• Excels in organizational abilities, effectively and efficiently managing multifaceted tasks and responsibilities with meticulous attention to detail
• Expertly utilizes persuasive strategies to gain acceptance of ideas and secure commitment to actions that support specific work outcomes.
• Proficient in interfacing with colleagues across functions and working independently in most situations, seeking guidance only in very complex scenarios.
• Exhibits exceptional adaptability; maintains effectiveness when experiencing major changes in work responsibilities or environment, adjusting adeptly to change.
• Demonstrates a proficient grasp of identifying and understanding problems and opportunities through gathering, analysing, and interpreting data for making timely decisions.
• Possesses an advanced understanding of pharmacovigilance and corporate procedures.
• Displays creative courage; proactively confronts difficult issues.
• Displays intermediate strategic thinking and project management skills, effectively prioritizing tasks while supporting projects

closing date for applications: 22/11/2024

Current Employees apply HERE

Current Contingent Workers apply HERE

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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. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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