Assoc. Spclst, Drug Safety

Job Description

The Associate Specialist, PV is responsible for undertaking specified PV activities (as delegated/assigned by their manager) and with oversight by their manager or a designated PV colleague. The Associate Specialist, PV is responsible for ensuring adherence to all applicable regulations, company policies and procedures.

 

The items listed below are activities that can be performed by the role as assigned by the manager and are applicable for all supported countries. Additional local specific tasks and responsibilities may be further described in the section below entitled “Additional Local Specific Activities”. 

 

• Assists with execution of local PV processes and activities in collaboration with internal functional areas and external parties as assigned. Activities may include but are not limited to management of local PV agreements, local due diligence activities, Post approval Safety Monitoring Program (PSMP) implementation, scheduling and submitting aggregate safety reports.

• Assists with day-to-day adverse events case management which may include case intake (where needed), translations (English and/or local language, (as applicable)), acknowledgments, follow-up and submission activities in accordance with PV procedures and country regulations.

• Supports local PV audits and inspections when requested.

• Participates in issue management/compliance activities and assists in coordinating/preparing the necessary local corrective actions.

• Supports development and maintenance of local PV procedures and controlled documents.

• Supports PV self-inspections as required by PV Legislations (where applicable).

• Supports appropriate implementation and oversight of Risk Minimization Measures and Additional Risk Minimization Measures locally as per local procedure and local legislations.

• May be responsible for managing and performing local literature screening and assessment in accordance with company procedure and local requirements (as applicable).

• Support local implementation of applicable business continuity plans.

• Translates or QCs translation of applicable PV documents.

• Responsible for filing, storage and archiving of safety-related documentation in accordance with company policies and local requirements.
• Participates in special projects or rotational assignments within or outside of IPV as part of their professional development.
• Responsible for completing all required/applicable trainings assigned at time of hire and after hire, by the due dates and before performing the activity.

Education:

• Health, life science, or medical science degree or equivalent by education/experience (Hiring Manager discretion permitted)

 

Work Experience:

• Experience in the pharmaceutical industry is preferred (Hiring Manager discretion permitted).

• General knowledge of AE reporting requirements and relevant PV regulations

 

Job-specific competencies & skills:

• Must be fluent in English (written and spoken) while proficient in local language

• Good communication, organizational, and time management skills 

Additional location(s) Compensation Information:

Required Skills:

Action Plan Development, Action Plan Development, Adverse Event Report, Communication, Compliance Activities, Compliance Investigations, Corrective Action Management, Data Analysis, Data Management, Data Processing, Data Quality Assurance, Detail-Oriented, Document Controls, Drug Safety Surveillance, Employee Training Programs, Functional Management, Medication Safety, Patient Safety, Personnel Selection, Pharmacology, Pharmacovigilance, Policy Implementation, Procedure Development, Protocol Development, Regulatory Audits {+ 9 more}

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:

Temporary (Fixed Term)

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

11/15/2026

*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.