Senior Specialist, Pharmacovigilance

Job Description

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

As a new addition to our Clinical Safety Team, we are looking for a Senior Specialist Pharmacovigilance (m/f/d) based in our Swiss subsidiary in Lucerne, Switzerland (Full-time, indefinite, hybrid).

The Senior Specialist, PV (m/f/d) is responsible for adverse event management including aggregate and individual case safety report (ICSR) health authority submissions and compliance monitoring. They are also responsible for PV activities (as delegated or assigned by their Manager) which may include but are not limited to:

• Responsible for execution of local PV processes and activities in collaboration with internal functional areas and external parties as assigned
• Serves as SME and supports local PV audits and inspections including readiness activities and supports other audits/inspections including the development of CAPAs in response to findings/observations
• Responsible for reporting adverse experiences or events (AE) or product quality complaints (PQCs) associated with the use of our company products in compliance with Corporate Policy 01: Patient Safety
• Participates in compliance activities and coordinates the preparation of necessary corrective actions locally for late reporting countries covered by the country operation
• Assists in developing and maintaining local procedures (in compliance with regional and global standards), to ensure global quality PV data and evaluates processes for potential improvement in efficiency and effectiveness
• Supports PV Lead in maintaining the local PV Training matrix and onboarding plans as assigned
• Supports the development and maintenance of local PV controlled documents (e.g., Company Core Pharmacovigilance Documents, training materials, etc. as applicable) ensuring that they are kept current
• Conducts and/or supports PV self-inspections as required by PV Legislations (where applicable)
• Proactively identifies procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders
• Responsible for completing all required/applicable trainings assigned at time of hire and after hire by the due dates, before performing the activity
• Supports training of local company staff, distributors, vendors, and business partners and can provide training as applicable
• Responsible for managing and performing local literature screening and assessment in accordance with company procedure and local 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)
• May be assigned responsibility for ensuring appropriate PV language is included in country PV agreements, liaising with business partners, vendors and Alliance Managers as required, performing local qualification/due diligence activities, compliance reviews, and ensuring maintenance of the business partner data tracking system
• May be responsible for reviewing, providing input and approving local initiatives (e.g., digital interfaces, marketing initiatives/ patient programs, organized data collection systems, etc.), and other programs to ensure compliance with PV requirements, as applicable
• As assigned by PV Lead, responsible for scheduling and coordinating submission activities for PSURs and other Aggregate Reports to the local Health Authority in compliance with company procedures and local legislation (as applicable)
• As assigned by PV Lead, responsible for ensuring appropriate implementation and oversight of Risk Minimization Measures, and Additional Risk Minimization Measures locally as per department policy and ensures compliance with local legislations
• Support local implementation of applicable business continuity plans (as applicable)
• Responsible for filing, storage and archiving of safety-related documentation in accordance with company's policies and local requirements
• Serves as local Subject Matter Expert on relevant PV regulations, processes and procedures
• Liaises with the local business units to keep them apprised of safety activities and provides input on strategic decisions
• Represents PV in cross-functional organizational and alliance partner forums as needed

Education:

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

Work Experience:

• Minimum 3 years experience in Pharmacovigilance or close related division of pharmaceutical industry is required
• Strong leadership, communication, decision making, and problem-solving skills
• In-depth knowledge of AE reporting requirements and 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 both English and German. Proficiency in French or Italian is a plus
• Excellent interpersonal communications, organizational, and presentation skills
• Excellent negotiation and influencing skills
• Ability to work in partnership with others (internally and externally) to accomplish quality goals
• 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
• Demonstrates strong strategic thinking and project management skills including prioritization of tasks

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

The Switzerland Head Office is based in Lucerne's city center. Located in the heart of the city, employees work collaboratively across many departments including commercial, market access, medical affairs, clinical research, regulatory affairs, and policy & communications. The site also serves as our regional and local headquarters for our company's Animal Health Division in Switzerland.

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:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date:07/01/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R295790