Job Description

Responsibilities:

Ensure timely, quality reports/safety analyses related to core deliverables with oversight as appropriate
- Collaborate with Therapeutic Area Safety Head (TASH)/MSO/Safety Surveillance Physician (SSP) and other
stakeholders on strategy development
- Initiate/Conduct/Oversee searches of internal and external databases
- Perform and/or lead aggregate safety analysis and case level review
- Author, contribute, and coordinate the preparation of core safety deliverables
- Ensure commitments (e.g., Pharmacovigilance Agreements (PVAs), assessment reports) are met
Provide SMT support as needed
- Act as ad hoc member for assigned products as appropriate
Training/Meetings/Department initiatives
- Participate in cross-functional training of relevant stakeholders
- Attend departmental meetings and trainings
- Participate in department and/or cross-functional initiatives
Recognize potential issues and or safety issues and escalate to the attention of the report owner, line manager, or
MSO
Review regulatory assessor comments/requests and accommodate/address as appropriate with guidance

Qualifications

Bachelor\xe2\x80\x99s/Master\xe2\x80\x99s degree in Pharmacy/related science area OR Bachelor\xe2\x80\x99s degree in Medical Science

Experience

At least 5-12 years\xe2\x80\x99 experience in the pharmaceutical industry, with at least 4 years of it in safety writing

Experience in drug discovery and pharmacovigilance, aggregate reports required - Ability to analyze and synthesize medical information

Experience on complex molecules or Pharma therapeutic segments preferable

Strong written and verbal language skills

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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Labcorp