Offers “Merckgroup”

Expires soon Merckgroup

Safety Scientist

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Job description



Safety Scientist

Your role:

Provides various office and location support activities. Identifies, enhances and follows specific processes and procedures to maximize the efficiencies of the business to which the support is being provided; ensures the correct functioning of facilities, office and/or business support services. The role is directly accountable for performing all pharmacovigilance (PV) tasks allocated to the Local Patient Safety organization under the supervision of the Local Patient Safety Officer (LPSO) in a given country/territory. Tasks have to be performed in full compliance with all relevant global and local regulatory requirements and company standards. This includes but not limited to:

1. Product safety surveillance• Handling of all local safety information, including collection, registration, translation from local language into English, and transmission to GPS as applicable in a timely manner• Seeking comprehensive initial and follow-up information on Individual Case Safety Reports (ICSRs) from all relevant spontaneous sources, and (where applicable) of cases from local interventional and non-interventional studies, Patient Data Collection Systems (PDCS) and quality complaints that are combined with adverse event information in a timely manner• Performing screening of relevant local medical/scientific literature in accordance with GPS procedures and local requirements• Performing screening of relevant local health authority web sites according to global standards as defined by relevant quality documents• Collaboration with medical information, quality assurance, complaint management and PDCSs to ensure safety reporting procedures are in place, safety relevant information is processed in a timely manner, and reconciliation is completed• Keeping product knowledge up-to-date to ensure appropriate Individual Case Safety Report (ICSR) handling• Performing required safety activities in the absence of the LPSO

2. Reporting to local Health Authorities and Ethics Committees• Timely submission of expedited ICSRs to concerned local health authorities (where applicable)• Support of e-reporting in e-reporting ready countries (where applicable)• Timely submission of expedited cases to concerned local/central EC/IRBs as applicable• Timely submission of safety issue reports to concerned local health authorities• Timely submission of safety issue reports to concerned local/central EC/IRBs as applicable

3. Compliance related activities• Using applicable tools (e.g. IRT) to ensure local compliance in terms of ICSR handling according to local regulations and company timelines• Supporting the LPSO to ensure compliance reports to GPS via the applicable technical tool (e.g. SCCT) in a timely manner• Contributions to the Local PV file in close collaboration with cross-functions to support completeness, accuracy and that relevant information is updated in a timely manner

4. Tracking of clinical development and Patient Data Collection Systems (PDCS) activities in the assigned countries• Supporting the LPSO that a complete overview on local / global clinical studies and PDCS (planned as well as ongoing) in the local affiliate is kept• Supporting the LPSO that current global procedures for the handling of PDCS and clinical studies are followed

5. Training activities• Completion of all mandatory PV trainings in a timely manner• Supporting PV training activities under the supervision of the LPSO• Supporting the LPSO in PV related trainings as required

 

6. Include additional responsibilities as per local requirement

 

Who you are:

•Medical, pharmaceutical or health care background or relevant working experience

• Fluent in written and spoken local language and English

•Experience in in the pharmaceutical industry or health authority (thereof 2-3 years in patient safety)

•Good knowledge of local regulatory PV legislation• Good understanding of drug development and life-cycle management

•Strong intercultural skills (developed from practical experience)• Strong team-working skills – working across cultural and functional boundaries, and participating ‘virtual teams’• Good problem-solving and decision-making ability• Good organizational skills, ability to prioritize work and adapt rapidly to changing priorities• Ability to manage multiple situations/issues under time pressure• Effective presentation and training skills

 

HR: 95601

Functional area: Research and Development

 

 

Job Requisition ID: 209302

Location: Beijing

Career Level: D - Professional (4-9 years)

Working time model: full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

Job Segment: Medical, Scientist, Pharmacovigilance, Pharmaceutical, Healthcare, Science, Research

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