Job Description
His/Her tasks depend on the Process/role assigned: Registry and Case Processing, Junior PV Lead, Reviewer.
- Perform registry and case assignment tasks as needed.
- Perform data entry/review of all adverse experience information received and processed within internal database within the established timeframes.
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Through daily case prioritization activities, reports are completed within the established timeframes to ensure compliance with internal, business partner, and regulatory agency reporting requirements.- Participate/perform in training and certification activities for JPV.
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Secondary Language(s) Job Description:
Other activities that the Safety Data Specialist can assume depending of the role:
- Provide team support by ensuring the appropriate resources such as SOPs and product/protocol guidelines are available and routinely updated to ensure the quality of reports.
- Identify coordinator, team, training and/or processes related issues and escalate to JPV liaison, JPV trainer or DMC JPV management as appropriate.
- Actively participate and ensure effective communication with different roles in Japan PV Safety, DMCs and other areas.
- Perform case review of adverse experience information within the established timeframes to be compliant with internal, business partner, and regulatory agency reporting requirements worldwide.
- Assist managers with reviewing individual coordinator report quality.
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:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Requisition ID:R242328