Manufacturing Technical Specialist I BC Forward
South San Francisco, CA19 days ago
- $30 Per Hour
- Full-time
| Location | San Rafael, CA |
b'nnnnnnnn Pharmacovigilance Associate II | BioMarinnnnn n n nnntntntntntntntntntntntntntntntntnnnnnnnnnnnnnnnnnnnnnnn nn
n
n n
n
tttt n n n
n n n
n
n n n n
n
n n n n
n
n n n n
n
n n n n
n
n n n n
n n
n
n ttttttn n n n
n
n n n
n
n Searchn
n n n tn tttttttttttttttn
n
n
n n
n
n n n n tttttttn
n
n n
n
n
ttn
n
n n
n Search BioMarinn n n
n n
n
n
n nnnnn n
n
n
n Back to Jobsn
n
n
nn
nn n n nn n n n n
n San Rafaeln
n n n
n
n n n
n BioMarin Pharmaceuticaln
nn
n n
Pharmacovigilance Associate II
n
Location: San Rafael, United States
n
Workstyle: Hybrid
n
Apply
n nn
n
Who We Are
n
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
n
Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
n
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best xe2x80x93 people with the right technical expertise and a relentless drive to solve real problems xe2x80x93 and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, wexe2x80x99ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
n
The mission of the Pharmacovigilance (PV) function is to lead multidisciplinary efforts to actively and effectively monitor the safety of Pharmacovigilance products throughout their lifecycle, rapidly act on validated new safety information, and ensure a state of global PV compliance.xc2xa0
n
Summary
The Associate is responsible for case initiation, data entry for non-expedited ICSRs, quality review and submissionsxc2xa0
The Associate II position requires a solid foundational ability to communicate well and work collaboratively on a team and a good level of competence to act proactively and effectively respond to workflow challenges. An aptitude for effective decision-making and problem-solving is also required.xc2xa0
n
Key Responsibilities:
xc2xa0
Case Initiation and Processingxc2xa0
xc2xb7xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Monitor the BPV Inbox and Argus safety database for receipt of safety information routinely throughout the business dayxc2xa0
xc2xb7xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Promptly review all relevant incoming items, using source document(s) to assess whether the case is valid and checking for duplicate cases; initiate all initial reports into the safety database per appropriate work instructionxc2xa0
xc2xa0
Case Initiation and Processingxc2xa0
xc2xb7xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Monitor the BPV Inbox and Argus safety database for receipt of safety information routinely throughout the business dayxc2xa0
xc2xb7xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Promptly review all relevant incoming items, using source document(s) to assess whether the case is valid and checking for duplicate cases; initiate all initial reports into the safety database per appropriate work instructionxc2xa0
xc2xb7xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Perform data entry for all non-serious ICSRs and all serious, non-expedited ICSRs (serious ICSRs with no regulatory submissions), ensuring timelines are metxc2xa0
xc2xb7xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Ensure all pending actions are completed and earliest received cases are prioritized; leverage email classification systems to categorize and prioritize incoming casesxc2xa0
xc2xb7xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Process follow up cases / previously reported events xc2xa0
xc2xb7xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Confirm receipt of case information by forwarding confirmation of safety reports received and providing Pharmacovigilance case numbers to appropriate partnersxc2xa0
xc2xb7xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Perform quality review. Review the source documentation to identify data which should be entered into the safety database, including review of all applicable data entered to assure accuracy. xc2xa0
xc2xb7xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Support submissions, including submitting reports to regulatory authorities and business partners and supporting the development of the cover letter and 1571 form for IND safety reports. Resolve submission problems as necessary.xc2xa0
xc2xb7xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 Conduct reconciliation of vendor / partners safety database with Pharmacovigilance safety databasexc2xa0
xc2xa0
Education & Experience:
xc2xb7xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 BA/BS degree in health or life sciences. Relevant experience in lieu of education accepted.
xc2xb7xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0xc2xa0 3+ years of pharmacovigilance experience
n
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
n
Equal Opportunity Employer/Veterans/Disabled
n
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
n n
nn
Apply
n n
n
n
n
n
Recruitment Fraud Alert Notice
n
n
n
n
Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent BioMarin in recruitment activities. We have an established recruitment process which is required for all posted positions by BioMarin prior to issuing an offer of employment. This BioMarin process requires formal interviews conducted live with personnel representing BioMarin and never requires payments or fees from job applicants. BioMarin does not conduct interviews via texting tools such as RingCentral.
n
In the event you receive a suspicious email message about recruiting on behalf of BioMarin, unless it's from a BioMarin authorized recruiting partner, do not provide any personal information or pay any fees. Qualified and interested candidates should apply to current openings directly through this BioMarin website. BioMarin accepts no responsibility for any costs or charges incurred as a result of fraudulent activity.
n
If you have lost money or provided your personal identifying information, please contact your bank and report the matter to the FBI via www.ic3.gov. We would also suggest you notify your local police department and monitor your credit.
n
For more information on how to recognize and report phishing scams visit: https://consumer.ftc.gov/articles/how-recognize-and-avoid-phishing-scams or https://consumer.ftc.gov/consumer-alerts/2023/01/looking-job-scammers-might-be-looking-you
n
n
n
n n
Equal Opportunity Employer/Veterans/Disabled
n
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
n
If you have a disability and believe you need a reasonable accommodation in order to search for a job opening or apply for a position, emailxc2xa0Applicant_accommodations@bmrn.comxc2xa0with your request.
nThis email address is not for general employment inquiries or correspondence. We will only respond to those requests that are related to the accessibility of the online application system due to a disability.
n
BioMarin Pharmaceutical does not accept unsolicited resumes from recruiters or agencies and we will not be responsible for any fees related to resumes that are unsolicited. We handle all recruiting through our Talent Acquisition team xe2x80x93 please do not contact hiring managers directly. Agencies who wish to offer their services to BioMarin Pharmaceutical may contact us atxc2xa0talentacquisition@bmrn.com.
nApplicants, please do not use this email address to submit resumes xe2x80x93 if you do so, you will be redirected to apply through the website.
n
Click here to review "EEO Is The Law" poster.xc2xa0Click here to review the Pay Transparency Nondiscrimination Statement.xc2xa0Click here to review the Notification of Employee Rights under Federal Labor Laws.
n
n
nn
nn nnn
n n
nt
ttntt
nttttttntttt
ntttttSearch JobsntttttntttttLocationntttttntttttSearch RadiusnttttttttttnttttttWithin 5 milesnttttttWithin 10 milesnttttttWithin 25 milesnttttttWithin 50 milesnttttttWithin 100 milesnttttttWithin 500 milesttttttntttttntttttntttttntttttntttt
ttttntttntt
ttnt
n
nnnnn
nt
nt
ntt
nttt
ntttt
Youxe2x80x99re leaving the BioMarin website.
ntttt
Links to sites outside of this website are provided as a resource to the viewer. BioMarin accepts no responsibility for the content of linked sites.
ntttt
ntttttLeave this websitentttttClosentttt
nttt
ntt
nt
n
nt
nt
ntt
nttt
ntttt
Enter your DIN number
ntttt
Please locate the 8-digit DIN number found on your product package or educational materials and enter it in the form below to access important safety information.
nttttnttttt
nttttttDIN numbernttttttnttttttnttttttnttttt
nttttt
nttttntttt
ttttntttttntttt
nttt
ntt
nt
n
nnn n n n
n
n n
n n
n
n Contactn n
n
n Legaln n
n
n
n
n
n
n
nn
n
n n
n
n 2026n BioMarin. All rights reserved.
n
n
nnnnnnnnnnnn'