Sr. Pharmacovigilance Scientist

Alkermes

8d•$145,000 - $158,000•Hybrid

About The Position

The Senior PV Scientist serves as a critical medical analytic and coordinating role in partnership with the Safety MD/Medical Monitor for assigned marketed and/or investigational product(s). The Senior PV Scientist is expected to be equally effective in working collaboratively or independently. She/he must demonstrate effective leadership skills with cross functional partners to ensure that signaling, safety data analyses/authorship for ad hoc queries and aggregate reports are of high quality and are completed and submitted according to required timelines. For investigational products, this role may also participate in protocol design, safety CRF development, safety monitoring plan, support of DSMB activities, coding review as well as SAE reconciliation activities. The Senior PV Scientist also plays a key role in ensuring that the above activities remain compliant with evolving regulations, that respective SOPs and work instructions regarding signaling, ad hoc and aggregate safety and risk management reports are adequate. The successful candidate will have demonstrated successful mastery of the above responsibilities in their work. Accountability and a sense of urgency in leading/managing projects is a key success factor for this role. Demonstrated ability to assimilate clinical data, and through its analyses/review be able to make crisp assessments and be able to communicate this effectively both verbally and in writing plays a critical capability in this job. This position will report to the Principal Scientist of DSPV.

Requirements

Minimum 5 years relevant medical, scientific/clinical, or pharmaceutical experience, including 3 years of experience in drug safety serving in a PV Scientist role
Demonstrated experience in analysis and interpretation of medical and scientific data and excellent verbal and written skills
Demonstrated ability to work effectively either independently or collaboratively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues
Demonstrated ability to prioritize multiple assignments and proactively identify solutions, as needed
Strong organizational, project management and leadership skills: Leads and conducts (independently and/or collaboratively) all aspects of substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests. Oversees and mentors less experienced PV Scientist staff
Scientifically sound and clinically accurate approaches to interpret data involving patient safety. Familiarity with pharmacovigilance and drug development, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes familiarity with case processing, expedited reporting rules, and safety database concepts
Strong knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects), MedDRA, and Argus Safety System
Advanced degree (PharmD, RN, MD, PhD, MPH, NP)

Responsibilities

For assigned product(s): Coordinate and document ongoing safety surveillance activities with the safety physician. Activities will include safety data review, signal validations, signal evaluations
Lead aggregate report (PSUR/PADER/DSUR) activities, including vendor oversight and project management, database requests, data analysis, report authoring, and quality checks
Manage literature review plan for assigned product(s) and provide feedback to vendor on routine literature surveillance activities
In collaboration with the safety physician, prepare materials for routine and ad hoc Safety Governance meetings (product- and leadership-level meetings)
Coordinate responses for ad hoc safety queries (eg, health authority requests, NISS, or health hazard evaluations) in collaboration with the safety physician and cross functional team members, as needed.
Perform safety data analyses, draft query responses, and prepare documents for cross functional review and finalization
Represent safety (with safety physician) and cross functional product meetings
For investigational product(s): Support activities relevant to investigational program including (but not limited to): Routine/ad hoc updates to safety content of Investigator Brochure (IB), safety content of protocols, CRFs, ICFs Routine DSMB presentations Ongoing data review, including lab, vitals, ECG, and AE data review Review preliminary data and prepare presentations for safety review committees
Maintain strong working knowledge of relevant regulations associated with the above activities
Contributes to initiatives for process improvement and cross-product process consistency
Other tasks as assigned or required