Associate Manager, Pharmacovigilance Job

Date: Jun 10, 2019

Location: Beijing, 11, CN

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Requisition ID: DRU000964

Major Activities and Responsibilities

1. Review case report and provide company causality assessment (CCA)
2. Review protocol for development products to ensure the company SOP and country regulations are fully met.
3. Review protocol for observational studies.
4. Provide safety guidance to internal clinical operation team and external stakeholders for clinical study.
5. Develop Safety Monitoring Plan(SMP) for outsourced study and handle related archiving and BDLM uploading activities.
6. Provide SAE training to CRO.
7. Conduct data reconciliation for outsourced study in collaboration with CRO.
8. Work with VBU to assist the patient compensation request
9. Develop SDEA(safety data exchange agreement) with business partner.
10. Provide KtR training to business Partner and vendor
11. Review marketing program and patient support program to ensure the company request has been correctly followed.
12. Develop vendor agreement with vendor and handle related administrative activities
13. Work with other internal stakeholders to deal with potential crisis.
14. Serve as the back up person when Vaccine/WH PV Lead is absence.

Qualifications

Qualifications

Background Requirements
The incumbent must have a health, life science, or medical science degree or equivalent by education / experience and should have a minimum 4 years of pharmacovigilance experience. He/she must have a sound knowledge of Pharmacovigilance regulations within his/her assigned country(ies). The candidate is expected to have strong communication and pay attention to details, and have the ability to work independently with minimal supervision.


Functional competencies

PV Intelligence
- knowledge of pharmacovigilance systems & requirements
- understanding of pharmacovigilance principles, concepts, practices & standards
- knowledge of the local country(ies) pharmacovigilance regulations & obligations
- knowledge of Good Clinical Practice concepts
- knowledge of local industry code(s) of practice
- understanding of risk management

Skills

Communication skills
- excellent written & spoken English
- ability to communicate effectively verbally and in writing
- proficient in local language(s)
- proficient in Good Documentation Practices
- basic presentation skills


Computer skills
- good word processing, presentation & spreadsheet application skills
- proficient in the use of a safety database
- ability to learn new computer interface systems

Personal
- High level of accuracy & quality in work
- Strong collaboration skills with the ability to work across boundaries
- Sense of urgency and the ability to make rapid, disciplined decisions
- Compliance mindset/focused
- Courage and candor
- Good problem solving capability
- Good training skills
- Good leadership and interpersonal skills




Job: Drug/Dvcs Sfty Survnce (NonMD)
Other Locations:
Employee Status: Regular
Travel:
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


Job Segment: Assistant Manager, Pharmacovigilance, Medical, Editor, Risk Management, Management, Healthcare, Publishing, Finance

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