Sr. Spclst, Drug Safety

Job description

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: Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully 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: 07/16/2026*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.