Job Description
The Associate Director, Pharmacovigilance Partner Strategy & Management (PV-PSM) is responsible for PV management of all Company relationships, including business development partners, third-party vendors/suppliers, and emerging data sources. This role is responsible for independent negotiation and maintenance of business partner and vendor PV agreements and leadership of the Global Clinical Safety & Pharmacovigilance (GCS&PV) implementation activities for partner deals including but not limited to, acquisitions and divestiture deals. This role has accountability for the negotiation of safety management plans (SMPs) with Company CRO partners and the development/implementation of cross-divisional PV policy to enable enterprise-wide activities to be conducted in compliant ways for our emerging data sources such as patient support programs and social media.
Key Responsibilities
Independently 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.
Maintains, in collaboration with the Executive Director/Director/ Associate Director PV-PSM, the internal guidelines and procedures for creating, updating and retention of PV agreements, PV plans, and SMPs.
Oversight of due diligence, capability assessments, and compliance review of partners and third-party vendors/suppliers.
Responsible for ensuring the transfer of safety data to or from the partner is appropriate and complete. Assesses the requirements and liaises within the Pharmacovigilance Operations team to ensure appropriate data and/or algorithms are updated appropriately based on the requirements of the agreement.
Collaborates with Executive Director/Director/Associate Director, PV-PSM to ensure training needs are assessed; creates and implements appropriate training as applicable in regard to new processes for each PV agreement.
End-to-end responsibility for the GCS&PV implementation and maintenance for all business development deals and third-party vendor/supplier agreements.
Act as point of PV contact for inspections and audits related to Company partnerships.
Interact closely with Legal, Business Development, Procurement, Human Health, and Alliance Management and other internal cross-functional stakeholders through the execution of strong processes for managing business development, third-party vendors/suppliers, and emerging data source deals as required to ensure consistency in PV policy implementation and processes globally.
Core Responsibilities
Knowledgeable of global regulatory requirements at a general level.
Maintains, the internal guidelines and procedures for creating, updating and retention of PV agreements and SMPs.
Interact closely with the system owner for the maintenance of the Business Development Lifecycle Management system.
Develop and support processes that facilitate achievement of GCS&PV objectives.
The Associate Director may also have people management responsibilities related to oversight of team members in supporting opportunities in a similar manner as described above. Additionally, responsible for employee development and management consistent with Company leadership principles.
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 conceptual and analytical thinking skills
Excellent word processing, SharePoint excel, e-mail, and online meeting tool skills
Demonstrated ability to manage multiple priorities and make effective, timely decisions
Demonstrated ability to network, collaborate, and communicate across cultures, organizational levels and disciplines
Demonstrated sensitivity and knowledge of cultural differences
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Education and Experience:
BS Degree preferably in Technical discipline (science, engineering) or Life Sciences (Biology, Chemistry, Nursing, Pharmacy) or related discipline
At least 5 years pharmacovigilance experience or related areas such as Clinical Risk Management, Clinical, or Regulatory
Required Skills:
Adaptability, Adaptability, Adverse Event Report, Auditing, Audit Inspections, Business Development, Business Management, Business Management Systems, Clinical Risk Management, Compliance Monitoring, Compliance Reviews, Data Management, Global Program Development, Life Science, Mergers and Acquisitions (M&A), People Management, Pharmaceutical Regulatory Compliance, Pharmacovigilance, Process Improvements, Procurement, Program Implementation, Regulatory Compliance, Regulatory Reporting, Safety Management, Strategic Planning {+ 1 more}
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:
Hybrid
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
NA
Job Posting End Date:
07/15/2026
*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.