Senior Drug Safety Specialist, Pharmacovigilance Records & Compliance
45 Sidney Street Cambridge, MA 02139 US
Job Description
Reporting to the Associate Director, Drug Safety and Pharmacovigilance Compliance and Operations, you will play a pivotal role in drug safety activities, supporting records management and compliance across the clinical development and marketing programs. You will be a key contributor to the day-to-day operational activities of the department, ensuring that performed tasks comply with DSPV SOP’s, policies, industry standards, and applicable regulations.
What will you do?
- Identifies and supports the DSPV team with document management activities (e.g., electronic Trial Master File, Veeva), including maintaining electronic files internally, and collaborate cross- functionally with internal teams, CRO’s and vendors.
- Contribute to the quality management Drug Safety system including: ensuring department standards are met, training requirements, monitoring performance, implementing continuous improvement actions and documentation practices.
- Participates in the daily management and execution of compliance activities.
- Assists with document development requirements are identified and aligned to overall strategic objects.
- Assists with monitoring DSPV compliance with regulations, PV agreements and internal SOPs.
- Function on supporting teams for projects in support of DSPV results.
- Supports sponsor oversight of AE/SAE processing by outsourced vendors, including the review and monitoring of compliance through various monitoring reports and other oversight activities and ensures the implementation of effective corrective and preventative action plans.
- Assist with working with DSPV and QA departments to maintain a state of high PV inspection readiness across all regions/countries.
- Participates in regulatory inspections and company audits including FDA/MHRA/EMA PV inspections; assists with prepares responses to audit findings that concern the DSPV department.
- Bachelor’s degree in nursing, pharmacy, or other health care related field.
- 2+ years of experience in a pharmaceutical industry setting within Drug safety, Pharmacovigilance, or the equivalent.
- Demonstrated experience with Electronic Document Management System(s).
- Proficiency in Microsoft Word, Power Point, Excel, Adobe, and Visio.
- Excellent oral and written communication skills.
- Strong analytical and problem-solving skills with superb attention to detail.
- Strong technical written, verbal, and presentation skills.
- Global pharmacovigilance operations experience with products in development preferred.
- Experience working with CROs, vendors, and other relationship management.
- Must work efficiently and collaboratively, in a fast-paced, team-oriented environment with individuals at all levels.
- Knowledge of FDA and EU legislation and ICH Efficacy guidelines.
- Proven track record working within a cross-functional, matrixed team.
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