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Pharmacovigilance/ Risk Management Specialist
To leverage my Pharmacovigilance experience and knowledge of guidelines and regulations to garner greater technical writing and scientific expertise, to contribute continuously to flourish my organization. To acquire great leadership skills in a professional environment with a challenging position in the area of Pharmacovigilance, while being resourceful, innovative, flexible and to produce world class results.
Clinical Pharmacovigilance/Drug Safety
About Me
Industry: |
Science & Biotech |
|---|---|
Occupation: |
Clinical Pharmacovigilance/Drug Safety |
Highlights: |
Managed a compliance of 100% Represented team during Audits and Inspections. |
Ideal Companies: |
Bristol Myers Squibb, Regeneron, Pharmacyclics, Gilead, Amgen, Johnson and Johnson, Celgene, UCB, Onyx, Novartis, |
Education level: |
Master |
Will Relocate: |
Yes |
Major Responsibilities
To author aggregate safety reports such as Periodic Safety Update Reports (PSUR), Periodic Adverse Drug Event Reports (PADER), Development Safety Update Reports (DSUR), Annual Safety Reports, ad-hoc safety reports and analysis, and risk management and pharmacovigilance plans.
To author safety section of IND- Annual reports, DSURs and to contribute towards CCDS updates.
Provide technical and scientific support to the Medical Safety Physicians (MSP) in all activities related to signal detection and risk management planning, including review and analysis of safety data reports arising from post marketing surveillance data and clinical trials.
Contribute to risk management plan authoring activities, as needed, with supervision (including sections of Risk Management or Pharmacovigilance Plans, REMS, follow- up of safety related post-approval regulatory commitments, etc.).
To support RMP/REMS sub teams or other teams responding to ad-hoc agency queries. Interact collaboratively with key internal and external partners to assure prompt and appropriate communication and resolution to safety issues.
Contribute to culture of open communication, alignment around shared business objectives, and constant process improvement. 8. To monitor compliance metrics of Aggregate Reports on a quarterly basis and alert Global compliance team for any lateness and CAPA activities
