Associate Manager, Pharmacovigilance Job

Date: Jan 30, 2019

Location: Beijing, 11, CN

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Requisition ID: DRU000848

Compliance Responsibilities: (comprising about 90 percent of time)

• Conduct protocol review to ensure the PV language is properly addressed according to China regulation and participate in the CSA/NDA filing to provide PV support for filing package (e.g. RMP, CSR, LPC, etc.)
• Serve as PV expert in the assigned oncology studies and post marketing programs to resolve any safety issues including deliver study SAE training to investigators, clinical operation team and CRO, etc.
• Develop the PV agreement /contract with vendor, BP or CRO for oncology products.
• Prepare the safety summary for license renewal for assigned oncology products.
• Work closely with Medical Affairs, DPOC, Sales/Marketing on any potential safety related issues for oncology products.
• Translate and process spontaneous and solicited / clinical trial adverse events reports from China and other countries according to China regulation or forward to a designated data entry center or contractual partners
• Conduct follow-up as required
• Conduct reconciliation of adverse events reports received from other operating units(e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners, as applicable
• , as applicable, spontaneous and solicited/clinical trial individual case safety reports(ICSRs) from China to the local Health Authorities
• File, store, and archive safety-related data
• Serves as back-up coverage in the absence of the Sr. Manager, Pharmacovigilance to ensure business continuity

• Comply with PV regulations and Global Safety policies/procedures and when needed take corrective action
• Participate in individual cases safety report compliance activities and takes the necessary corrective actions locally for late reporting within their country/territory
• Prepare for audits/inspections for their country/territories and participates in the audit and/or inspection
• Identify and communicate potential safety issues
• Deliver training to PV staff and customer facing non-PV staff(e.g., Sales Reps, Medical Information, etc.) and distributors
• Train and mentor PV staff
• Complete and document required PV training within required timelines
• Perform other activities as requested by the Director, PV
• Perform specific delegated tasks from the Director, PV (e.g., local training coordinator, local SOP coordinator, etc.)

Key Interactions: (comprising about 10 percent of time)
• Serve as the point of contact for the local Health Authority or liaise with the Global Regulatory Affairs (GRA) / Global Medical Affairs (GMA) colleagues for questions from the Health Authorities regarding safety and ICSRs in absence of the Sr. Manager, PV.
• Liaise with the Country Leaders and colleagues in Global Clinical Trial Operations (GCTO), Global Regulatory Affairs (GRA), Global Medical Affairs (GMA) and other business units to ensure processes are in place for activities that are performed by those functions which impact PV.
• Liaise with the EU QP PV in consultation with Global Safety Regional Leader or Global Safety MoW / EU Leader in the absence of the Sr. Manager, PV.
• Liaise with PV Regional Centers/Data Management Centers.
• Participate on corporate sponsored committees and councils (i.e., Medical Governance Council) in the absence of the Sr. Manager, PV.

Qualifications

BACKGROUND REQUIREMENTS
List the minimum academic credentials, professional certifications, years of experience and specific skills required for this position.

The incumbent must have a health, life science, or medical science degree and be fluent in English while proficient in local language. He/she should have at a minimum 5 years of industry experience in Pharmacovigilance. The Associate Manager, PV must have extensive knowledge of Pharmacovigilance regulations in their country/territory. He/She is expected to have strong communication and time management skills and have the ability to work independently with minimal supervision.

Core competencies:

Prioritizing, Planning, Accountability: Accurately scopes out length and difficulty of tasks and projects; prioritizes to meet business objectives and goals; anticipates and adjusts for problems and roadblocks; measures performance against goals and is accountable.
Learning on the fly – A quick learner, open to change and challenges, looks for learning in both successes and failures, strives to identify and apply best practices.
Peer Relationships – Can quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration.
Time management – uses time effectively, works efficiently, is able to prioritize activities, seeks guidance on prioritization when necessary.
Dealing with Ambiguity – Can effectively cope with change; can shift gears comfortably; can decide and act without having the total picture; isn’t upset when things are up in the air; doesn’t have to finish things before moving on; can comfortably handle risk and uncertainty.
Personal Learning – Picks up on the need to change personal, interpersonal and managerial behavior quickly; watches others for their reactions to his/her attempts to influence and perform, and adjust; seeks feedback.

Advanced Competencies:
Interpersonal Savvy – Relates well to all kinds of people, up, down, and sideways, inside and outside the organization; builds appropriate rapport; builds constructive and effective relationships; uses diplomacy and tact; can diffuse even high-tension situations comfortably.
Decision Quality – Makes good decisions (without considering how much time it takes) based upon a mixture of analysis, wisdom, experience, and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions.
Organizing – Can orchestrate multiple activities at once to accomplish a goal; uses resources effectively and efficiently;
arranges information and files in a useful manner.

TECHNICAL COMPETENCIES:
List the technical competencies, related elements and proficiency levels required for this position.
PV Intelligence
- knowledge of pharmacovigilance systems & requirements
- knowledge of local industry code(s) of practice
- understanding of pharmacovigilance principles, concepts, practices & standards
- understanding of risk management
Regulatory Competency
- knowledge of the local pharmacovigilance regulations & obligations
- basic understanding of Good Clinical Practice concepts
Communication skills
- excellent written & spoken English
- proficient in local language
- basic presentation skills
- ability to communicate effectively verbally and in writing
- proficient in Good Documentation Practices
Computer skills
- good word processing, presentation & spreadsheet application skills
- proficient in use of a global safety database
- ability to learn new computer interface systems



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


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