Sr. Spclst, Drug Safety

Job Description

The Senior Specialist PV-PSM is responsible for management of all Company relationships including business development partners third-party vendors/suppliers and emerging data sources. May be responsible for negotiation and maintenance of business partner and vendor PV agreements. May be responsible for the negotiation of safety management plans (SMPs) with Company CRO partners and PV Plans.

Key Responsibilities

Contribute to and provide subject matter expertise for PV templates for business development partners third-party vendors/suppliers and emerging data source deals to ensure compliance with global PV regulations.

• Under the direction of the Executive Director/Director/Associate Director Pharmacovigilance (PV) Partner Strategy & Management (PV-PSM) organizes conducts and/or facilitates meetings with business development partners CRO partners third-party vendors/suppliers and internal stakeholders for the negotiation implementation and maintenance of PV agreements PV plans and SMPs.

• Leads due diligence capability assessments and compliance review of partners and third-party vendors/suppliers.

• Maintains PV global standards for relevant activities to ensure compliance and quality of PV requirements.

• Develops and maintains the necessary processes to ensure high quality individual case and aggregate safety reporting in accordance with pharmacovigilance (PV) policy and regulations.

• Creates and implements appropriate training as applicable in regard to new processes for each PV agreement.

• Provides support for inspections and audits related to Company partnerships.

• Collaborate with the system owner for the maintenance of the Business Development Lifecycle Management system.

Core Responsibilities

• Participate in interdepartmental and interdivisional meetings in support of individual program reviews input for PV requirements and related processes.

• Collaborate inter-divisionally to ensure PV requirements are incorporated into business processes standards and resources.

• Identify prioritize and monitor quality issues to be resolved to maintain compliance.

• Develop and support processes that facilitate achievement of GCS&PV objectives

• May support some or all of the above responsibilities and/or any other project or perform any other task deemed appropriate by management.

Required Qualifications & Skills:

Strong knowledge base of pharmacovigilance principles

Excellent communication and interpersonal skills

Attention to detail and ability to be flexible in order to meet daily competing priorities of the business

Ability to independently manage projects and drive projects to completion

Strong knowledge base of pharmacovigilance regulations

Demonstrate leadership and proficiency managing across organizations

Education and Experience:

• BS Degree preferably in Technical discipline (science engineering) or Life Sciences (Biology Chemistry Nursing Pharmacy) or related discipline

• At least 2 years pharmacovigilance experience or related areas such as Clinical Risk Management Clinical or Regulatory

Required Skills:

Adaptability Adverse Event Report Auditing Business Management Systems Business Processes Chemical Biology Clinical Risk Management Compliance Monitoring Compliance Reviews Data Analysis Decision Making Drug Safety Surveillance Life Science Multi-Management Partnership Strategy Pharmaceutical Regulatory Compliance Pharmacovigilance Regulatory Compliance Regulatory Reporting Risk Management Safety Management Strategic Planning Training and Development Veterinary Products

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.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

NA

Job Posting End Date:

08/15/2026

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