Pharmacovigilance Specialist - 9 months contract
Pharmacovigilance Specialist - 9 months contract
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1 Vacancy
Job Description
Job Description
This is a temporary role for a 9 months duration.
As the Pharmacovigilance (PV) Specialist you will be responsible for specified PV activities (as delegated/assigned by your manager) and are able to perform these tasks with minimal supervision. You will also be 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.
1. Responsible for execution of local PV processes and activities in collaboration with applicable internal functional areas and external parties ensuring alignment with local legislation and local/regional/global company procedures and policies. Activities may include but are not limited to management and negotiation of local PV agreements local due diligence activities Post approval Safety Monitoring Program (PSMP) implementation scheduling and coordinating aggregate safety report submissions conducting local training review of local initiatives for compliance with PV requirements communication of safety issues.
2. Responsible for execution of local PV processes and activities in collaboration with internal functional areas and external parties as assigned.
3. Responsible for day-to-day adverse events case management which may include case intake translations (English and/or local language (as applicable)) acknowledgments follow-up and submission activities in accordance with PV procedures and country regulations.
4. Supports local PV business partner and vendor audits and inspections including readiness activities document requests and CAPA activities.
5. Participates in issue management/compliance activities and coordinates / prepares the necessary local corrective actions.
6. Supports development and maintenance of local PV procedures and controlled documents in compliance with local regional and global standards to ensure global quality PV data.
7. Supports PV self-inspections as required by PV Legislations (where applicable).
8. May be assigned responsibility for ensuring appropriate implementation and oversight of Risk Minimization Measures and Additional Risk Minimization Measures locally as per department policy and local legislations.
9. Prepare/maintain/submit local RMPs to the local HA (as applicable).
10. May be responsible for managing and performing local literature screening and assessment in accordance with company procedure and local requirements (as applicable).
11. Support local implementation of applicable business continuity plans
12. Responsible for filing storage and archiving of safety-related documentation in accordance with company policies and local requirements.
13. Serves as local Subject Matter Expert on relevant PV regulations processes and procedures.
14. Translates or QCs translation of applicable PV documents.
15. Supports PV Lead in maintaining the local PV Training matrix and onboarding plans.
16. 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
17. May be responsible for Health Authority Website Monitoring for potential safety issues safety alerts and new/revised PV requirementsin compliance with company proceduresand local legislation (as applicable).
18. Liaises with the local business units to keep them apprised of safety activities and provides input on strategic decisions.
19. Represents PV in cross-functional organizational and alliance partner forums as needed.
20. Participates on local company committees and councils for matters impacting PV as assigned. 21. Participates in special projects or rotational assignments within or outside of IPV as part of their professional development.
22. 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
Work Experience:
- At least 1 year of PV experience in the pharmaceutical industry is preferred.
- 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.
- Demonstrates proficiency in communication organizational and time management skills.
- Ability to work in partnership with others (internally and externally).
- Ability to interface broadlywith 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.
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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:
Not ApplicableShift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Adaptability Adverse Event Report Business Continuity Communication Compliance Investigations Data Analysis Data Management Detail-Oriented Periodic Safety Update Reports Pharmacovigilance Regulatory Compliance Risk Management Working IndependentlyPreferred Skills:
Job Posting End Date:
09/22/2025*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.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
