Drug Safety Case Manager
Drug Safety Case Manager
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$ 150100 - 165900
1 Vacancy
Job Description
Cytokinetics is a latestage specialty cardiovascular biopharmaceutical company focused on discovering developing and commercializing firstinclass muscle activators and nextinclass muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.
Job purpose
The Drug Safety Case Manager will support the daytoday functioning of the Drug Safety Department. The candidate will have a key a role in development implementation and maintenance of a quality system for all Drug Safety activities encompassing processes procedures compliance and metrics.
Responsibilities
- Ensures that all safety reports received from any source for Cytokinetics products are processed in the safety database and reported according to ICHGCP guidelines regulatory requirements and company SOPs Work Instructions departmental procedures and business partner agreements
- Assists in overseeing the CRO processing SAE reports on Cytokinetics products in accordance with all applicable regulations guidelines and SOPs. This includes detailed review of source documentation assessing cases for reportability generation of analysis of similar events quality check.
- Processes adverse event related information in drug safety database for Cytokinetics products including the writing of narratives for expedited and nonexpedited reports.
- Coordinates follow up for missing or ambiguous safety data.
- Coordinates the production of safety data outputs from the Safety database for analyses and reports.
- Maintains regulatory and department compliance by ensuring timely completion of reports and assisting in submissions of reportable cases to regulatory agencies study investigators and licensing partners as needed.
- Participates is Study Operation Team meetings for assigned studies and leads the PVrelated study activities including preparation of study startup activities (e.g. development of studyspecific Safety Management Plans training of internal /external projectteam members in safetyreporting processes development of safety report forms safety data reconciliation site initiation training activities)
- Liaises with other functional groups for implementation of PVrelated processes requiring cross functional collaboration such as SAE data reconciliation between Clinical and Safety databases.
- Evaluates project or case workflow and offers solutions for process improvement.
- May represent the Drug Safety Department in crossfunctional team meetings.
- Conducts periodic reconciliation of SAEs between the drug safety and clinical trial databases for ongoing clinical studies.
- Drafts and updates departmental SOPs and other work practices as assigned and maintains consistency with regulatory guidelines and good pharmacovigilance practices.
- Participates in training internal and external audiences on drug safetyrelated topics as assigned.
- Maintains a high level of understanding of federal and international regulations and guidance so as to guide departmental policies and procedures.
- Assists with the preparation of periodic safety reports as assigned
- Assists with preparation of safety data presentations for departmental meetings (e.g. Drug Safety Committee Meetings)
- Assists with the mentoring training and support for departmental team members for high quality and consistent of daily activities in the Drug Safety Department
- Acts as Subject Matter Expert (SME) for safety related activities
- Participates in the creation of the department strategy goals and objectives and assists in the implementation of new safety initiatives and new Health Authority safety requirements.
Qualifications
- Degree in life sciences. Health care professional (pharmacy nursing or equivalent) is strongly preferred
- 3 to 5 years of experience in drug safety with broad exposure to various PVrelated activities including ICSR activities and periodic reports.
- Broad knowledge of domestic and international drug safety regulations industry practices and standards.
- Experience with drug safety databases (e.g. Argus ARISg)
- Excellent working knowledge of MedDRA and WHODRUG coding dictionaries
- Demonstrated ability to work effectively collaboratively under minimal supervision with a sense of urgency in a dynamic crossfunction matrix environment
- Proficiency in the use of relevant computer systems including MS Word Excel PowerPoint and Outlook
- Strong interpersonal written and oral communication skills and professionalism
- Strong organizational skills detail oriented and adapts in a dynamic fastpaced environment.
Pay Range:
In the U.S. the hiring pay range for fully qualified candidates is $150100 $165900 USD per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidates geographic region jobrelated knowledge skills and experience among other factors.Our employees come from different backgrounds and we celebrate those differences. We are looking for the best candidates for our open roles but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team we would love to hear from you.
Please review ourGeneral Data Protection Regulation (GDPR) policyPRIOR to applying.
Our passion is anchored in robust scientific thinking grounded in integrity and critical thinking. We keep the patient front and center in all we do all actions and decisions are in service of the patient and their caregivers. We champion integrity ethics doing the right thing and being our best selves.
Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers
Recently there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain () and will only be made after completing a formal interview process.
Here are some ways to check for authenticity:
We do not conduct job interviews through nonstandard text messaging applications
We will never request personal information such as banking details until after an official offer has been accepted and verified
We will never request that you purchase equipment or other items when interviewing or hiring
If you are unsure about the authenticity of an offer or if you receive any suspicious communication please contact us directly at
Cytokinetics is an Equal Opportunity Employer
Required Experience:
Manager
Employment Type
Full-Time
